CN112691278B - Ureter and bladder catheter and method of introducing negative pressure to increase renal perfusion - Google Patents
Ureter and bladder catheter and method of introducing negative pressure to increase renal perfusion Download PDFInfo
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- CN112691278B CN112691278B CN202011552114.9A CN202011552114A CN112691278B CN 112691278 B CN112691278 B CN 112691278B CN 202011552114 A CN202011552114 A CN 202011552114A CN 112691278 B CN112691278 B CN 112691278B
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- ureteral
- kidney
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Abstract
The present invention relates to ureteral and bladder catheters and methods of introducing negative pressure to increase renal perfusion. Providing ureteral catheters and assemblies comprising: a catheter comprising a proximal portion configured to be positioned in at least a portion of a patient's urethra and a distal portion configured to be positioned in a patient's ureter and/or kidney, the distal portion comprising a coiled retention portion comprising at least a first coil having a first diameter and a second coil having a second diameter, the first diameter being smaller than the second diameter; or wherein the retention portion extends radially outwardly from a portion of the distal end of the catheter section, the retention portion comprising a proximal end having a first diameter, a distal end having a second diameter, and walls and/or surfaces extending therebetween, the retention portion having a second diameter that is greater than the first diameter when deployed; or wherein the retention portion comprises a plurality of catheters.
Description
Cross Reference to Related Applications
The present application claims the benefit of U.S. provisional application number 62/194,585 filed on day 20, 7, 2015, U.S. provisional application number 62/260,966 filed on day 11, 30, 2016, 1, 14, and 2016, U.S. provisional application number 62/300,025 filed on day 25, 2, each of which is incorporated herein by reference in its entirety.
Background.
Technical Field
The present disclosure relates to methods and devices for treating impaired renal function that afflict a variety of disease states, and in particular, to catheter devices, assemblies, and methods for urine collection and/or introducing negative pressure in the ureter and/or kidney.
Background
The kidney or urinary system includes a pair of kidneys, each connected to the bladder through a ureter, for draining urine produced by the kidneys from the bladder. Kidneys perform several vital functions of the human body including, for example, filtering blood to expel waste in the form of urine. Kidneys also regulate electrolytes (e.g., sodium, potassium, and calcium) and metabolites, blood volume, blood pressure, blood pH, fluid volume, erythrocyte production, and bone metabolism. It is useful to fully understand the anatomy and physiology of the kidney to understand the effects of altered hemodynamic and other fluid overload conditions on its function.
In normal anatomy, two kidneys are located in the abdominal cavity retroperitoneum. Kidney is a bean-shaped envelope tissue. Urine is formed by the nephron, the functional unit of the kidney, and then flows through a convergent tubule (called the urinary tract) system. The collecting ducts join together to form a renal calyx, which then form a renal calyx, which finally join near the recess of the kidney (renal pelvis). The main function of the renal pelvis is to direct urine flow to the ureter. Urine flows from the renal pelvis into the ureter, a tubular structure that carries urine from the kidneys to the bladder. The outer layer of the kidney, called the cortex, is a hard fibrous wrap. The interior of the kidney is called the medulla. The medullary structure is arranged in cone.
Each kidney consists of approximately 100 tens of thousands of nephrons. Each nephron includes a glomerulus, a kidney pouch and a tubule. The tubules include proximal tubules, loop loops, distal tubules and collecting ducts. The nephrons contained in the cortex are different from the anatomy of the nephrons contained in the medulla. The main difference is the length of the loop. The medullary nephron contains a longer loop, which normally allows greater regulation of water and sodium reabsorption than in the cortical nephron.
The glomeruli are the origin of the nephron, responsible for the initial filtration of the blood. The intraglomerular arterioles pass blood through glomerular capillaries where hydrostatic pressure pushes water and solutes into the renal vesicles. The net filtration pressure is expressed as hydrostatic pressure in the afferent glomerular arterioles decreasing hydrostatic pressure in the renal capsule lumen decreasing osmotic pressure in the glomerular arterioles.
Net filtration overpressure = hydrostatic pressure (afferent arterioles) -hydrostatic pressure (renal small sac lumen) -osmotic pressure (efferent arterioles) (equation 1)
The magnitude of this net filtered overpressure, determined by equation 1, determines how much ultrafiltrate is formed in the renal capsule lumen and delivered to the tubules. The remaining blood leaves the pellet through the out-of-pellet arterioles. Normal glomerular filtration or delivery of ultrafiltrate to the tubules is about 90ml/min/1.73m 2 。
The glomeruli have a three-layer filtering structure that includes vascular endothelium, glomerular basement membrane and podocytes. In general, large proteins such as albumin and erythrocytes do not penetrate the renal small capsule lumen. However, elevated glomerular pressure and inflation of the mesangial membrane causes a change in surface area on the basal membrane and larger perforations between podocytes allowing larger proteins to pass into the renal capsule lumen.
Ultrafiltrate collected in the renal capsule lumen is first delivered to the proximal tubular. Reabsorption and excretion of water and solutes in the tubules occurs through a mixture of active transport channels and passive pressure gradients. The proximal tubules typically reabsorb most of the sodium chloride and water, as well as substantially all of the glucose and amino acids filtered through the pellets. The loop has two components designed to concentrate waste in urine. The drop leg is highly permeable and reabsorbs most of the remaining water. The ascending branch reabsorbs 25% of the remaining sodium chloride, producing concentrated urine, for example in terms of urea and creatinine. The distal tubules typically reabsorb a small portion of sodium chloride and the osmotic gradient creates conditions for water follow-up.
Under normal conditions, there is a net filtration of about 14 mmHg. The effect of venous congestion may be a significant decrease in net filtration, down to about 4mmHg. See Jessup m., the cardiorenal syndrome: do we need a change of strategy or a change of tactics? , JACC53 (7) 597-600,2009 (hereinafter also referred to as "Jessup"). The second filtration stage occurs at the proximal tubule. Most of the excretion and absorption from urine occurs in the tubules of the medullary nephron. Active transport of sodium from the tubule to the interstitial space initiates this process. However, hydrostatic forces govern the net exchange of solutes and water. Under normal conditions, 75% of the sodium is considered to be reabsorbed back into the lymphatic or venous circulation. However, because the kidneys are enveloped, they are sensitive to changes in hydrostatic pressure from both venous and lymphatic congestion. During venous engorgement, sodium and water retention may exceed 85%, allowing renal engorgement to continue further. See Verbruge et al The kidney in congestive heart failure: are patriuresis, sodium, and diruetucs really the good, the bad and the ugly?European Journal of Heart Failure2014:16,133-42 (hereinafter also "Verbrugge”)。
Venous engorgement may lead to a prerenal form of Acute Kidney Injury (AKI). Prerenal AKI is caused by loss of perfusion (or loss of blood flow) through the kidneys. Many clinicians focus on the lack of injection into the kidney due to shock. However, there is also evidence that lack of blood flow out of the organ due to venous congestion may be a clinically significant sustained injury. See Damman K, importance of venous congestion for worsening renal function in advanced decompensated heart failure, JACC 17:589-96,2009 (hereinafter also "Damman").
Prerenal AKI occurs in a variety of diagnoses requiring admission to critical conditions. The most prominent admission is due to sepsis and Acute Decompensated Heart Failure (ADHF). Other admissions include cardiovascular surgery, general surgery, cirrhosis, trauma, burns and pancreatitis. Despite the wide clinical variability in the presentation of these disease states, it is common that central venous pressure increases. In the case of ADHF, elevated central venous pressure caused by heart failure leads to pulmonary oedema, followed by dyspnea and thus to hospitalization. In the case of sepsis, the central venous pressure rise is mostly the result of aggressive fluid resuscitation. Regardless of whether the initial injury is hypo-perfusion due to reduced blood volume or sodium and fluid retention, the sustained injury is venous congestion that causes improper perfusion.
Hypertension is another widely recognized condition that causes disturbances in the renal's active and passive transport systems. Hypertension directly affects the osmotic arterial pressure and results in a proportional increase in net filtered overpressure in the pellet. The increase in filtration fraction also increases peritubular capillary blood pressure, which stimulates sodium and water reabsorption. See verbruge.
Because the kidney is an envelope organ, it is sensitive to pressure changes in the medullary cone. Elevated renal venous pressure causes congestion, resulting in elevated interstitial pressure. The increase in interstitial pressure applies a force to both the pellets and the tubules. See Verburgge. In the pellet, the interstitial pressure rise directly counteracts the filtration. The pressure rise increases the interstitial fluid, thus increasing hydrostatic pressure in the interstitial fluid and small Guan Zhou capillaries in the renal medulla. In both cases, hypoxia can then cause cells Injury and further loss of perfusion. The net result is that sodium and water reabsorption that produces negative feedback is further exacerbated. See verbruge, 133-42. Fluid overload, particularly in the abdominal cavity, is associated with a number of diseases and conditions, including elevated intra-abdominal pressure, ventricular compartment syndrome, and acute renal failure. Fluid overload can be overcome by renal replacement therapy. See Peters, c.d., short and Long-Term Effects of the Angiotensin II Receptor Blocker Irbesartanon Intradialytic Central Hemodynamics: A Randomized Double-blank Placebo-Controlled One-Year Intervention Trial (the SAFIR Study), PLoS ONE (2015) 10 (6): e 01266882. Doi: 10.1371/journ. Fine. 01266882 (hereinafter also "Peters"). However, this clinical strategy does not provide renal function improvement to patients suffering from cardiorenal syndrome. See Bart B, ultrafiltration in decompensated heart failure with cardiorenal syndrome,NEJM2012, a part of the material; 367:2296-2304 (hereinafter also referred to as "Bart").
In view of this problematic role of fluid retention, there is a need for devices and methods for improving the drainage of urine from the urinary tract, and in particular for improving the quantity and quality of urine output from the kidneys.
Summary of The Invention
In some examples, a ureteral catheter is provided that includes: a drainage lumen (drainage lumen) comprising a proximal portion configured to be positioned in at least a portion of a patient's urethra and a distal portion configured to be positioned in a patient's ureter and/or kidney, the distal portion comprising a coiled retention portion (retention portion), wherein the retention portion comprises at least a first coil having a first diameter and a second coil having a second diameter, the first diameter being less than the second diameter.
In some examples, a urine collection assembly is provided that includes: at least one ureteral catheter, comprising: a fluid lumen comprising a proximal portion configured to be positioned in at least a portion of a patient's urethra and a distal portion configured to be positioned in a patient's ureter and/or kidney, the distal portion comprising a coiled retention portion, wherein the retention portion comprises at least a first coil having a first diameter and a second coil having a second diameter, the first diameter being smaller than the second diameter; and a bladder catheter deployed within a patient's bladder, the bladder catheter comprising: a drainage lumen portion defining a drainage lumen and including a proximal end, a distal end configured to be positioned in a patient's bladder, and a sidewall extending therebetween; and a deployable anchor portion comprising a closure cap configured to contact a proximal portion of a bladder wall to substantially or completely close a urethral meatus of the bladder, wherein the drainage lumen portion or anchor portion comprises at least one drainage port (drainage port) that allows fluid to flow into the drainage lumen.
In some examples, a ureteral catheter is provided that includes: a drainage lumen portion comprising a proximal end, a distal end configured to be positioned in a ureter and/or kidney of a patient, and a sidewall extending therebetween; and a retention portion extending radially outwardly from a portion of the distal end of the catheter portion, the retention portion including a proximal end having a first diameter, a distal end having a second diameter, and walls and/or surfaces extending therebetween, the retention portion configured to extend to a deployed position in which the second diameter is greater than the first diameter.
In some examples, a urine collection assembly is provided that includes: at least one ureteral catheter, comprising: a drainage lumen portion comprising a proximal end, a distal end configured to be positioned in a ureter and/or kidney of a patient, and a sidewall extending therebetween; and a retention portion extending radially outwardly from a portion of the distal end of the catheter section, the retention portion comprising a proximal end having a first diameter, a distal end having a second diameter, and walls and/or surfaces extending therebetween, the retention portion configured to extend to a deployed position wherein the second diameter is greater than the first diameter; and a bladder catheter deployed within a patient's bladder, the bladder catheter comprising: a drainage lumen portion defining a drainage lumen and including a proximal end, a distal end configured to be positioned in a patient's bladder, and a sidewall extending therebetween; and a deployable anchor portion comprising a closure cap configured to contact a proximal portion of the bladder wall to close the urethral meatus of the bladder, wherein the drainage lumen portion or anchor portion comprises at least one drainage port that allows fluid to flow into the drainage lumen.
In some examples, a ureteral catheter is provided that includes: a drainage lumen portion comprising a proximal end, a distal end configured to be positioned in a ureter and/or a kidney of a patient, and a sidewall extending therebetween, the drainage lumen portion defining a drainage lumen; and a retention portion extending radially outwardly from a portion of the distal end of the manway portion at the deployed position, the retention portion comprising a plurality of tubes extending between the proximal end of the retention portion and the distal end of the retention portion, wherein each tube defines a lumen in fluid communication with the manway defined by the manway portion, and wherein each tube comprises a plurality of manways allowing fluid to enter the lumen.
In some examples, a urine collection assembly is provided that includes: at least one ureteral catheter, comprising: a drainage lumen portion comprising a proximal end, a distal end configured to be positioned in a ureter and/or a kidney of a patient, and a sidewall extending therebetween, the drainage lumen portion defining a drainage lumen; and a retention portion extending radially outwardly from a portion of the distal end of the manway portion at the deployed position, the retention portion comprising a plurality of tubes extending between the proximal end of the retention portion and the distal end of the retention portion, wherein each tube defines a lumen in fluid communication with the manway defined by the manway portion, and wherein each tube comprises a plurality of manways allowing fluid to enter the lumen; a bladder catheter for deployment within a patient's bladder, the bladder catheter comprising: a drainage lumen portion defining a drainage lumen and including a proximal end, a distal end configured to be positioned in a patient's bladder, and a sidewall extending therebetween; and a deployable anchor portion comprising a closure cap configured to contact a proximal portion of the bladder wall to close the urethral meatus of the bladder, wherein the drainage lumen portion or anchor portion comprises at least one drainage port that allows fluid to flow into the drainage lumen.
In some examples, a connector is provided for connecting a ureteral catheter configured to be positioned in a ureter and/or a kidney of a patient with a vacuum source for introducing negative pressure into the ureter and/or kidney and for connecting a bladder catheter with a fluid collection container for fluid collection of urine from the bladder by gravity drainage, the connector comprising: a connector body; first and second ureteral catheter inflow ports extending from the connector body, each configured to connect with a ureteral catheter located in a ureter and/or a kidney of a patient; ureteral catheter outflow openings in fluid communication with each inflow opening and configured to be connected to a pump for introducing negative pressure into each ureteral catheter; a gravity drainage flow inlet configured to connect with a bladder catheter; and a gravity drainage outlet in fluid communication with the bladder conduit inflow port and configured to connect with a fluid collection container.
In some examples, a urine collection assembly is provided that includes: a first ureteral catheter configured to be located in a ureter and/or a kidney of a patient and a second ureteral catheter configured to be located in another ureter and/or kidney of the patient, the ureteral catheters each comprising: a drainage lumen portion defining a drainage lumen and including a proximal end, a distal end configured to be positioned in a ureter and/or a kidney of a patient, and a sidewall extending therebetween; a retention portion extending radially outwardly from a portion of the distal end of the manway portion and configured to extend to a deployed position wherein the diameter of the retention portion is greater than the diameter of the manway portion, wherein at least one of the manway portion or the retention portion includes at least one manway opening that allows fluid flow into the manway; a bladder catheter for deployment within a patient's bladder, the bladder catheter comprising: a drainage lumen portion defining a drainage lumen and including a proximal end, a distal end configured to be positioned in a patient's bladder, and a sidewall extending therebetween; and a deployable anchor portion comprising a closure cap configured to contact a proximal portion of the bladder wall to close the urethral meatus, wherein at least one of the drainage lumen portion or the anchor portion comprises at least one drainage port that allows fluid to flow into the drainage lumen.
In some examples, a bladder catheter for deployment in a patient's bladder for collecting excessive urine not collected by a deployed ureteral catheter located in a ureter and/or kidney of the patient is provided, the bladder catheter comprising: a drainage lumen portion defining a drainage lumen and including a proximal portion, a distal portion configured to be positioned in a patient's bladder, and a sidewall extending therebetween; and a deployable anchor portion configured to contact a proximal portion of the bladder wall to close the urethral meatus, wherein at least one of the drainage lumen portion or anchor portion comprises at least one drainage port that allows fluid to flow into the drainage lumen for draining urine from the bladder.
In some examples, a system for introducing negative pressure into a portion of a patient's urinary tract is provided, the system comprising: a ureteral catheter comprising: a drainage lumen portion comprising a proximal end, a distal end configured to be positioned in a ureter and/or kidney of a patient, and a sidewall extending therebetween; a retention portion extending radially outwardly from a portion of the distal end of the manway portion and configured to extend to a deployed position wherein the diameter of the retention portion is greater than the diameter of the manway portion, wherein at least one of the manway portion or the retention portion includes at least one manway opening that allows fluid flow into the manway; and a pump in fluid communication with a fluid lumen defined by the fluid lumen portion of the ureteral catheter, the pump configured to introduce negative pressure into a portion of a patient's urinary tract to aspirate fluid through the fluid lumen of the ureteral catheter.
Methods of using the above-described catheters and assemblies are also provided.
In some examples, a method for aspirating urine from a ureter and/or kidney of a patient to affect interstitial pressure in the kidney is provided, the method comprising: positioning a distal end of a catheter at a fluid collection site within a ureter and/or kidney of a patient, the catheter including a tube defining a fluid-conducting lumen and including a helical retention portion and a plurality of fluid-conducting ports; introducing negative pressure into the liquid guide cavity of the catheter; and suctioning urine through the fluid transfer port into the fluid transfer lumen, thereby altering interstitial pressure within the patient's kidney.
In some examples, methods are provided for preventing kidney injury by applying negative pressure to reduce interstitial pressure within the tubules of the medullary area to promote urine drainage and prevent venous hyperemia-induced nephron hypoxia in the renal medullary, the methods comprising: deploying a ureteral catheter in a ureter and/or a kidney of a patient such that flow of urine from the ureter and/or kidney is not prevented by the deployment catheter blocking the ureter and/or kidney; and applying negative pressure to the ureter and/or the kidney through the catheter for a predetermined period of time to promote urine drainage from the kidney.
In some examples, methods are provided for treating acute kidney injury caused by venous congestion, the methods comprising: deploying a ureteral catheter in a ureter and/or kidney of a patient at a fluid collection location such that the ureter and/or kidney is not occluded by the deployment catheter; and applying negative pressure to the ureter and/or the kidney through the catheter for a predetermined period of time, thereby relieving venous congestion in the kidney to treat acute kidney injury.
In some examples, methods are provided for treating new york heart association (New York Heart Association, NYHA) class III and/or class IV heart failure by alleviating venous congestion in the kidney, the methods comprising: deploying the ureteral catheter in the ureter and/or kidney of the patient such that the flow of urine from the ureter and/or kidney is not prevented by the ureter and/or kidney obstruction; and applying negative pressure to the ureter and/or kidney through the catheter for a predetermined period of time to treat volume overload of NYHA class III and/or class IV heart failure.
In some examples, there is provided a method of treating stage 4 and/or stage 5 chronic kidney disease by alleviating venous congestion in the kidney, the method comprising: deploying the ureteral catheter in the ureter and/or kidney of the patient such that the flow of urine from the ureter and/or kidney is not prevented by the ureter and/or kidney obstruction; and applying negative pressure to the ureter and/or the kidney through the catheter for a predetermined period of time to treat stage 4 and/or stage 5 chronic kidney disease.
Non-limiting examples, aspects or embodiments of the invention will now be described in terms of the following numbering:
item 1: a ureteral catheter comprising: comprising a proximal portion configured to be positioned in at least a portion of a patient's urethra and a distal portion configured to be positioned in a patient's ureter and/or kidney, the distal portion comprising a coiled retention portion, wherein the retention portion comprises at least a first coil having a first diameter and a second coil having a second diameter, the first diameter being smaller than the second diameter.
Item 2: the ureteral catheter of item 1, wherein the first coil is proximal to the second coil.
Item 3: the ureteral catheter of any of claims 1 or 2, wherein a portion of the fluid-guiding lumen that is proximal to the retention portion defines a straight or curved central axis prior to insertion into the urinary tract of the patient, and wherein the first coil and the second coil of the retention portion extend about an axis that is at least partially coextensive with the straight or curved central axis of the portion of the fluid-guiding lumen.
Item 4: the ureteral catheter of claim 1 or 2, wherein a portion of the fluid-guiding lumen that is proximal to the retention portion defines a straight or curved central axis prior to insertion into the urinary tract of the patient, and wherein the first coil and the second coil of the retention portion extend about an axis that is substantially coextensive with the straight or curved central axis of the portion of the fluid-guiding lumen.
Item 5: the ureteral catheter of item 3 or 4, wherein the axis of the retention portion is arcuate with respect to the central axis of the drainage lumen.
Item 6: the ureteral catheter of any of claims 1-5, wherein a portion of the fluid lumen that is proximal to the retention portion defines a straight or curved central axis, and wherein the first coil and the second coil of the retention portion extend about an axis of the retention portion that is positioned at an angle ranging from about 15 degrees to about 75 degrees from the central axis.
Item 7: the ureteral catheter of any of claims 1-6, wherein the catheter is convertible between a contracted shape for insertion into a patient ureter and a deployed shape for deployment within the ureter.
Item 8: the ureteral catheter of any of claims 1-7, wherein the retention portion further comprises a third coil, the third coil having a diameter that is greater than or equal to the first diameter or the second diameter.
Item 9: the ureteral catheter of any of claims 1-8, wherein the retention portion comprises a tube comprising perforations that allow fluid to be received within a lumen of the tube.
Item 10: the ureteral catheter of item 9, wherein in the retention portion, the tube comprises a radially inward side and a radially outward side, and wherein the total surface area of the perforations on the radially inward side is greater than the total surface area of the perforations on the radially outward side.
Item 11: the ureteral catheter of item 9, wherein in the retention portion the tube comprises a radially inward side and a radially outward side, and wherein the perforations are located radially inward side, and wherein the radially outward side of the tube is substantially free of perforations.
Item 12: the ureteral catheter of item 11, wherein the radially outward side of the tube is not perforated.
Item 13: the ureteral catheter of any of claims 1-12, wherein the tube is formed at least in part from one or more of copper, silver, gold, nickel titanium alloy, stainless steel, titanium, polyurethane, polyvinylchloride, polytetrafluoroethylene (PTFE), latex, and silicone.
Item 14: a urine collection assembly comprising: at least one ureteral catheter, comprising: a fluid lumen comprising a proximal portion configured to be positioned in at least a portion of a patient's urethra and a distal portion configured to be positioned in a patient's ureter and/or kidney, the distal portion comprising a coiled retention portion, wherein the retention portion comprises a first coil having at least a first diameter and a second coil having a second diameter, the first diameter being smaller than the second diameter; a bladder catheter for deployment within a patient's bladder, the bladder catheter comprising: a drainage lumen portion defining a drainage lumen and including a proximal end, a distal end configured to be positioned in a patient's bladder, and a sidewall extending therebetween; and a deployable anchor portion comprising a closure cap configured to contact a proximal portion of the bladder wall to substantially or completely close the urethral meatus of the bladder, wherein the drainage lumen portion or anchor portion comprises at least one drainage port that allows fluid to flow into the drainage lumen.
Item 15: the combination of claim 14, wherein the drainage lumen portion of the at least one ureteral catheter is movably received through the drainage port of the bladder catheter such that the proximal end of the at least one ureteral catheter is positioned within the drainage lumen of the bladder catheter.
Item 16: the combination of any one of claims 14 or 15, wherein the deployable anchor portion of the bladder catheter comprises an inflatable element or balloon in fluid communication with an inflation lumen defined by the liquid-guiding lumen portion of the bladder catheter.
Item 17: the combination of any one of claims 14-16, wherein at least one fluid port is disposed on a sidewall of the bladder catheter at a location proximal to the deployable anchor portion.
Item 18: the combination of any of claims 14-17, wherein the expandable fluke portion comprises an expandable cage comprising a plurality of flexible members extending radially and longitudinally from the drainage lumen portion of the bladder catheter.
Item 19: the combination of any one of claims 14-18, wherein the deployable anchor portion comprises a plurality of longitudinally extending members extending radially and longitudinally outwardly from a portion of the distal end of the bladder catheter at the deployed position, thereby forming a cage.
Item 20: the combination of item 18, wherein the deployable anchor further comprises a flexible cover extending around an upper portion of the cage.
Item 21: the combination of item 20, wherein the cover extends over at least about the upper half of the cage or at least about the upper 2/3.
Item 22: the assembly of any of claims 14-21, wherein the drainage lumen of the at least one ureteral catheter is separated from the drainage lumen of the bladder along the entire length of the catheter.
Item 23: a ureteral catheter comprising: a drainage lumen portion comprising a proximal end, a distal end configured to be positioned in a ureter and/or kidney of a patient, and a sidewall extending therebetween; and a retention portion extending radially outwardly from a portion of the distal end of the catheter portion, the retention portion including a proximal end having a first diameter, a distal end having a second diameter, and walls and/or surfaces extending therebetween, the retention portion configured to extend to a deployed position in which the second diameter is greater than the first diameter.
Item 24: the ureteral catheter of item 23, wherein the retention portion comprises an expandable element or balloon in fluid communication with an inflation lumen extending along the drainage lumen portion.
Item 25: the ureteral catheter of claim 23 or 24, wherein the retention portion comprises a coiled tube extending from a distal end of the lumen portion, the tube defining a lumen in fluid communication with the lumen defined by the lumen portion.
Item 26: the ureteral catheter of any of claims 23-25, wherein the coiled tube comprises perforations extending through a sidewall of the tube to allow fluid to be received within the lumen.
Item 27: the ureteral catheter of item 26, wherein the perforations are disposed on a radially inward portion of the tube, and wherein the tube is substantially free of perforations on an opposite radially outward portion of the tube.
Item 28: the ureteral catheter of item 27, wherein the opposing radially outward portions of the tube are free of perforations.
Item 29: the ureteral catheter of any of claims 23-28, wherein the drainage lumen portion and the retention portion are formed at least in part from one or more of copper, silver, gold, nickel-titanium alloy, stainless steel, titanium, polyurethane, polyvinylchloride, polytetrafluoroethylene (PTFE), latex, and silicone.
Item 30: the ureteral catheter of item 23, wherein the retention portion comprises a wedge-shaped or funnel-shaped extension formed from a compressible and/or porous material.
Item 31: the ureteral catheter of any of claims 23-30, wherein the retention portion is integrally formed with the drainage lumen portion.
Item 32: the ureteral catheter of any of claims 23-31, wherein the retention portion further comprises a tapered inner surface configured to direct liquid toward a fluid lumen defined by the fluid lumen portion.
Item 33: the ureteral catheter of any of claims 23-32, wherein the catheter's drainage lumen is configured to apply negative pressure for fluid collection of the ureter and/or kidney.
Item 34: a urine collection assembly comprising: at least one ureteral catheter, comprising: a drainage lumen portion comprising a proximal end, a distal end configured to be positioned in a ureter and/or kidney of a patient, and a sidewall extending therebetween; and a retention portion extending radially outwardly from a portion of the distal end of the catheter section, the retention portion comprising a proximal end having a first diameter, a distal end having a second diameter, and walls and/or surfaces extending therebetween, the retention portion configured to extend to a deployed position wherein the second diameter is greater than the first diameter; a bladder catheter for deployment within a patient's bladder, the bladder catheter comprising: a drainage lumen portion defining a drainage lumen and including a proximal end, a distal end configured to be positioned in a patient's bladder, and a sidewall extending therebetween; and a deployable anchor portion comprising a closure cap configured to contact a proximal portion of the bladder wall to close the urethral meatus of the bladder, wherein the drainage lumen portion or anchor portion comprises at least one drainage port that allows fluid to flow into the drainage lumen.
Item 35: the combination of claim 34, wherein the drainage lumen portion of the at least one ureteral catheter is movably received through the drainage port of the bladder catheter such that the proximal end of the at least one ureteral catheter is positioned within the drainage lumen of the bladder catheter.
Item 36: the assembly of claim 34 or 35, wherein the deployable anchor portion of the bladder catheter comprises an inflatable element or balloon in fluid communication with an inflation lumen defined by the liquid-guiding lumen portion of the bladder catheter.
Item 37: the combination of any one of claims 34-36, wherein at least one fluid port is disposed on a sidewall of the bladder catheter at a location proximal to the deployable anchor portion.
Item 38: the combination of item 34, wherein the expandable fluke portion comprises an expandable cage comprising a plurality of flexible members extending radially and longitudinally from the drainage lumen portion of the bladder catheter.
Item 39: the combination of item 34, wherein the deployable anchor portion comprises a plurality of longitudinally extending members extending radially and longitudinally outwardly from a portion of the distal end of the bladder catheter at the deployed position, thereby forming a cage.
Item 40: the combination of clause 38 or 39, wherein the deployable anchor further comprises a flexible cover extending around an upper portion of the cage.
Item 41: the combination of item 40, wherein the cover extends over at least about the upper half or at least about the upper 2/3 of the cage.
Item 42: a ureteral catheter comprising: a drainage lumen portion comprising a proximal end, a distal end configured to be positioned in a ureter and/or a kidney of a patient, and a sidewall extending therebetween, the drainage lumen portion defining a drainage lumen; and a retention portion extending radially outwardly from a portion of the distal end of the manway portion at the deployed position, the retention portion comprising a plurality of tubes extending between the proximal end of the retention portion and the distal end of the retention portion, wherein each tube defines a lumen in fluid communication with the manway defined by the manway portion, and wherein each tube comprises a plurality of manways allowing fluid to enter the lumen.
Item 43: the ureteral catheter of item 42, wherein each tube comprises a radially inward and a radially outward, and wherein the fluid-directing port is located radially inward of each tube.
Item 44: the ureteral catheter of item 43, wherein the radially outward side of each tube is substantially free of a stoma.
Item 45: the ureteral catheter of item 43, wherein the radially outward side of each tube is free of a stoma.
Item 46: the ureteral catheter of any of claims 42-45, wherein the retention portion is transitionable from a contracted position, wherein each of the plurality of tubes is substantially parallel to a longitudinal axis of the lumen portion and a deployed position in which the portion of the tube extends radially outward from the lumen portion.
Item 47: the ureteral catheter of any of claims 42-46, wherein the tube defines a spherical or oval lumen in the deployed position, and wherein the drainage lumen portion extends at least partially into the lumen.
Item 48: the ureteral catheter of any of claims 42-47, wherein the drainage lumen portion and the retention portion are formed at least in part from one or more of copper, silver, gold, nickel-titanium alloy, stainless steel, titanium, polyurethane, polyvinylchloride, polytetrafluoroethylene (PTFE), latex, and silicone.
Item 49: the ureteral catheter of any of claims 42-48, wherein the retention portion is integrally formed with the drainage lumen portion.
Item 50: the ureteral catheter of any of claims 42-49, wherein the catheter's drainage lumen is configured to apply negative pressure for fluid collection of the ureter and/or kidney.
Item 51: a urine collection assembly comprising: at least one ureteral catheter, comprising: a drainage lumen portion comprising a proximal end, a distal end configured to be positioned in a ureter and/or a kidney of a patient, and a sidewall extending therebetween, the drainage lumen portion defining a drainage lumen; a retention portion extending radially outwardly from a portion of the distal end of the manway portion at the deployed position, the retention portion comprising a plurality of tubes extending between the proximal end of the retention portion and the distal end of the retention portion, wherein each tube defines a lumen in fluid communication with a manway defined by the manway portion, and wherein each tube comprises a plurality of manways allowing fluid to enter the lumen; a bladder catheter for deployment within a patient's bladder, the bladder catheter comprising: a drainage lumen portion defining a drainage lumen and including a proximal end, a distal end configured to be positioned in a patient's bladder, and a sidewall extending therebetween; and a deployable anchor portion comprising a closure cap configured to contact a proximal portion of the bladder wall to close the urethral meatus of the bladder, wherein the drainage lumen portion or anchor portion comprises at least one drainage port that allows fluid to flow into the drainage lumen.
Item 52: the combination of item 51, wherein the drainage lumen portion of the at least one ureteral catheter is movably received through the drainage port of the bladder catheter such that the proximal end of the at least one ureteral catheter is positioned within the drainage lumen of the bladder catheter.
Item 53: the combination of clause 51 or 52, wherein the deployable anchor portion of the bladder catheter comprises an inflatable element or balloon in fluid communication with an inflation lumen defined by the liquid-guiding lumen portion of the bladder catheter.
Item 54: the assembly of any one of claims 51-53, wherein at least one fluid port is disposed on a sidewall of the bladder catheter at a location proximal to the deployable anchor portion.
Item 55: the combination of clause 51 or 52, wherein the expandable fluke portion comprises an expandable cage comprising a plurality of flexible members extending radially and longitudinally from the drainage lumen portion of the bladder catheter.
Item 56: the combination of clause 51 or 52, wherein the deployable anchor portion comprises a plurality of longitudinally extending members extending radially and longitudinally outward from a portion of the distal end of the bladder catheter at the deployed position, thereby forming a cage.
Item 57: the combination of clause 55 or 56, wherein the deployable anchor further comprises a flexible cover extending around an upper portion of the cage.
Item 58: the combination of item 57, wherein the cover extends over at least about the upper half or about the upper 2/3 of the cage.
Item 59: a connector for connecting a ureteral catheter configured to be positioned in a ureter and/or a kidney of a patient with a vacuum source for introducing negative pressure into the ureter and/or kidney and for connecting a bladder catheter with a fluid collection container for fluid collection of urine from the bladder by gravity drainage, the connector comprising: a connector body; first and second ureteral catheter inflow ports extending from the connector body, each configured to connect with a ureteral catheter located in a ureter and/or a kidney of a patient; ureteral catheter outflow openings in fluid communication with each inflow opening and configured to be connected to a pump for introducing negative pressure into each ureteral catheter; a gravity drainage flow inlet configured to connect with a bladder catheter; and a gravity drainage outlet in fluid communication with the bladder conduit inflow port and configured to connect with a fluid collection container.
Item 60: the connector of clause 59, wherein the connector body defines a fluid conduit extending from at least 2 ureteral catheter inflow openings to a single ureteral catheter outflow opening.
Item 61: the connector of clause 59 or 60, wherein the inflow port is configured to movably receive a distal end of each conduit.
Item 62: the connector of any one of claims 59-61, wherein the vacuum flow outlet and the gravity flow outlet are positioned for connection with a single socket to establish a fluid connection with the pump and the fluid connection container.
Item 63: a urine collection assembly comprising: a first ureteral catheter configured to be located in a ureter and/or a kidney of a patient and a second ureteral catheter configured to be located in another ureter and/or kidney of the patient, the ureteral catheters each comprising: a drainage lumen portion defining a drainage lumen and including a proximal end, a distal end configured to be positioned in a ureter and/or a kidney of a patient, and a sidewall extending therebetween; a retention portion extending radially outwardly from a portion of the distal end of the manway portion and configured to extend to a deployed position wherein the diameter of the retention portion is greater than the diameter of the manway portion, wherein at least one of the manway portion or the retention portion includes at least one manway opening that allows fluid flow into the manway; a bladder catheter for deployment within a patient's bladder, the bladder catheter comprising: a drainage lumen portion defining a drainage lumen and including a proximal end, a distal end configured to be positioned in a patient's bladder, and a sidewall extending therebetween; and a deployable anchor portion comprising a closure cap configured to contact a proximal portion of the bladder wall to close the urethral meatus, wherein at least one of the drainage lumen portion or the anchor portion comprises at least one drainage port that allows fluid to flow into the drainage lumen.
Item 64: the assembly of clause 63, further comprising a connector for connecting the proximal end of the ureteral catheter to a vacuum source and for connecting the proximal end of the bladder catheter to a fluid collection container for fluid collection by gravity drainage.
Item 65: the assembly of item 64, wherein the connector comprises: at least 2 ureteral catheter inflow ports for connection to proximal ends of the first ureteral catheter and the second ureteral catheter, respectively; ureteral catheter outflow openings in fluid communication with each inflow opening and configured to be connected to a pump for introducing negative pressure into each ureteral catheter; a gravity drainage flow inlet configured to connect with a proximal end of the bladder catheter; and an outflow port in fluid communication with the bladder conduit inflow port and configured to be connected to a fluid collection container.
Item 66: the combination of item 65, wherein the connector further comprises a conduit extending from the at least 2 ureteral catheter inflow openings to the single ureteral catheter outflow opening.
Item 67: the assembly of clause 65 or 66, wherein the proximal end of each conduit is movably connected to its respective inflow port.
Item 68: the assembly of any one of claims 63-67, wherein the deployable anchor portion of the bladder catheter comprises an inflatable element or balloon in fluid communication with an inflation lumen defined by the liquid-guiding lumen portion of the bladder catheter.
Item 69: the combination of clause 63, wherein the expandable fluke portion comprises an expandable cage comprising a plurality of flexible members extending radially and longitudinally from the mandril portion of the bladder catheter and a cover closing at least a portion of the cage.
Item 70: the combination of clause 68 or 69, wherein the deployable anchor further comprises a flexible cover extending around an upper portion of the cage.
Item 71: the combination of item 70, wherein the cover extends over at least about the upper half or at least about the upper 2/3 of the cage.
Item 72: a bladder catheter deployed within a patient's bladder for collecting excessive urine that is not collected by a deployed ureteral catheter located in a ureter and/or kidney of the patient, the bladder catheter comprising: a drainage lumen portion defining a drainage lumen and including a proximal portion, a distal portion configured to be positioned in a patient's bladder, and a sidewall extending therebetween; and a deployable anchor portion configured to contact a proximal portion of the bladder wall to close the urethral meatus, wherein at least one of the drainage lumen portion or anchor portion comprises at least one drainage port that allows fluid to flow into the drainage lumen for draining urine from the bladder.
Item 73: the urinary bladder catheter of clause 72, wherein the deployable anchor portion comprises an inflatable member or balloon in fluid communication with an inflation lumen defined by the liquid-guiding lumen portion of the urinary bladder catheter.
Item 74: the bladder catheter of clause 73, wherein the inflatable element or balloon comprises a bladder configured to be positioned in an upper portion of the patient's bladder and a lower portion configured to be positioned in the patient's urethra.
Item 75: the urinary bladder catheter of any one of claims 62-74, wherein at least one fluid transfer port is disposed on a sidewall of the urinary bladder catheter at a location proximal to the anchor hook portion.
Item 76: the bladder catheter of clause 72, wherein the expandable anchor portion comprises an expandable cage comprising a plurality of flexible members extending radially and longitudinally from the drainage lumen portion of the bladder catheter and a cover closing at least a portion of the cage.
Item 77: the bladder catheter of item 76, wherein the deployable anchor portion further comprises a flexible cover extending around an upper portion of the cage.
Item 78: the bladder catheter of item 77, wherein the cover extends over at least about the upper half of the cage or at least about the upper 2/3.
Item 79: a system for introducing negative pressure into a portion of a patient's urinary tract, the system comprising: a ureteral catheter comprising: a drainage lumen portion comprising a proximal end, a distal end configured to be positioned in a ureter and/or kidney of a patient, and a sidewall extending therebetween; a retention portion extending radially outwardly from a portion of the distal end of the manway portion and configured to extend to a deployed position wherein the diameter of the retention portion is greater than the diameter of the manway portion, wherein at least one of the manway portion or the retention portion includes at least one manway opening that allows fluid flow into the manway; and a pump in fluid communication with a fluid lumen defined by the fluid lumen portion of the ureteral catheter, the pump configured to introduce negative pressure into a portion of a patient's urinary tract to aspirate fluid through the fluid lumen of the ureteral catheter.
Item 80: the system of clause 79, further comprising: a bladder catheter for deployment within a patient's bladder, the bladder catheter comprising: a drainage lumen portion defining a drainage lumen and including a proximal end, a distal end configured to be positioned in a patient's bladder, and a sidewall extending therebetween; and a deployable anchor portion comprising a closure cap configured to contact a proximal portion of the bladder wall to close the urethral meatus, wherein at least one of the drainage lumen portion or anchor portion comprises at least one drainage port that allows fluid to flow into the drainage lumen for draining urine from the bladder.
Item 81: the system of clause 80, further comprising an external fluid collection container in fluid communication with the drainage lumen of the bladder catheter for gravity drainage of fluid through the bladder catheter.
Item 82: the system of any one of claims 79-81, further comprising one or more sensors in fluid communication with the fluid conducting lumen, the one or more sensors configured to determine information including at least one of capacitance, analyte concentration, and temperature of urine within each fluid conducting lumen; and a processor comprising a computer readable memory including programming instructions that when executed cause the processor to: information from the one or more sensors is received and an operating parameter of the pump is adjusted to increase or decrease a vacuum pressure in the lumen of the at least one ureteral catheter to regulate the flow of urine through the lumen based at least in part on the information received from the one or more sensors.
Item 83: the system of clause 82, further comprising a data transmitter in communication with the processor, the data transmitter configured to provide information from the one or more sensors to an external source.
Item 84: the system of any one of claims 80-83, wherein the pump provides a sensitivity of 10mmHg or less.
Item 85: the system of any one of claims 80-84, wherein the pump is capable of continuous operation for a period of time ranging from about 8 to about 24 hours per day.
Item 86: the system of any one of claims 80-85, wherein the pump is configured to provide intermittent negative pressure.
Item 87: the system of any one of claims 80-86, wherein the pump is configured to independently apply negative pressure to each conduit such that the pressure of each conduit is the same or different than the other conduits.
Item 88: the system of any one of claims 80-86, wherein the pump is configured to alternate between providing a negative pressure and providing a positive pressure.
Item 89: the system of any of claims 80-86, wherein the pump is configured to alternate between providing negative pressure and balancing pressure to atmospheric pressure.
Item 90: the system of clause 88, wherein a negative pressure in the range of 5mmHg to 50mmHg is provided, and/or wherein a positive pressure in the range of 5mmHg to 20mmHg is provided.
Item 91: the system of any one of claims 80-90, wherein the pump is configured to alternate between two or more different pressure levels.
Item 92: the system of clause 91, wherein the pump is configured to adjust the pressure level at a regular or irregular frequency based at least in part on a predetermined algorithm.
Item 93: the system of clause 92, wherein the predetermined algorithm is based in part on demographic data and/or patient-specific variables.
Item 94: the system of clause 93, wherein the demographic data and/or patient-specific variables include one or more of anatomical, genetic, physiological, and pathophysiological factors.
Item 95: the system of clause 92, wherein the predetermined algorithm is based in part on continuously or discontinuously changing patient values including one or more of urine flow rate, peristaltic activity of the kidney and/or urinary system, heart rate, cardiac output, blood pressure, respiration rate, renal blood flow, renal plasma flow, and biomarkers.
Item 96: a method for aspirating urine from a ureter and/or a kidney of a patient to affect interstitial pressure in the kidney, the method comprising: positioning a distal end of a catheter at a fluid collection site within a ureter and/or kidney of a patient, the catheter including a tube defining a fluid-conducting lumen and including a helical retention portion and a plurality of fluid-conducting ports; introducing negative pressure into the liquid guide cavity of the catheter; and suctioning urine through the fluid transfer port into the fluid transfer lumen, thereby altering interstitial pressure within the patient's kidney.
Item 97: the method of clause 96, wherein positioning the catheter comprises deploying the catheter at the fluid collection location by extending the helical retention portion.
Item 98: the method of clause 96 or 97, further comprising placing the distal end of the bladder catheter into the patient's bladder and deploying the anchor hook within the bladder such that the anchor hook substantially or completely occludes the urethral sphincter of the bladder.
Item 99: the method of claim 98, wherein placing the bladder catheter in the bladder comprises advancing the bladder catheter over a guide wire for ureteral catheter positioning.
Item 100: a method of inhibiting kidney injury by applying negative pressure to reduce interstitial pressure within the tubules of the medullary area to promote urine drainage and prevent venous congestion-induced nephron hypoxia in the renal medullary, the method comprising: deploying a ureteral catheter in a ureter and/or a kidney of a patient such that flow of urine from the ureter and/or kidney is not prevented by the deployment catheter blocking the ureter and/or kidney; and applying negative pressure to the ureter and/or the kidney through the catheter for a period of time sufficient to facilitate urine drainage from the kidney.
Item 101: the method of clause 100, further comprising placing the bladder catheter in the patient's bladder such that the anchor hook of the bladder catheter substantially or completely occludes the urinary sphincter of the bladder.
Item 102: the method of clause 101, further comprising draining urine from the bladder through the bladder catheter for a period of time.
Item 103: the method of claim 100, wherein deploying the catheter comprises accessing the ureter and/or kidney through an incision or orifice other than a urethral orifice.
Item 104: a method for treating acute kidney injury caused by venous congestion, the method comprising: deploying the ureteral catheter in the ureter and/or kidney of the patient such that the flow of urine from the ureter and/or kidney is not prevented by the ureter and/or kidney obstruction; and applying negative pressure to the ureter and/or the kidney through the catheter for a period of time sufficient to treat acute kidney injury caused by venous congestion.
Item 105: a method of treating NYHA class III and/or class IV heart failure by reducing venous congestion in the kidneys, the method comprising: deploying the ureteral catheter in the ureter and/or kidney of the patient such that the flow of urine from the ureter and/or kidney is not prevented by the ureter and/or kidney obstruction; and applying negative pressure to the ureter and/or kidney through the catheter for a period of time sufficient to treat NYHA class III and/or class IV heart failure.
Item 106: a method of treating NYHA class II, class III and/or class IV heart failure by reducing venous congestion in the kidneys, the method comprising: deploying the catheter in the patient's bladder such that urine flow from the ureter and/or kidney into the bladder is not prevented by the blockage; and applying negative pressure to the bladder through the catheter for a period of time sufficient to treat NYHA class II, class III and/or class IV heart failure.
Item 107: a method of treating stage 4 and/or stage 5 chronic kidney disease by alleviating venous congestion in the kidney, the method comprising: deploying a ureteral catheter in a ureter and/or a kidney of a patient such that flow of urine from the ureter and/or the kidney is not prevented by a ureter and/or kidney obstruction; and applying negative pressure to the ureter and/or kidney through the catheter for a period of time sufficient to treat stage 4 and/or stage 5 chronic kidney disease.
Item 108: a method of treating stage 3, stage 4 and/or stage 5 chronic kidney disease by alleviating venous congestion in the kidney, the method comprising: deploying the catheter in the patient's bladder such that flow of urine from the ureter and/or kidney is not prevented by the blockage; and applying negative pressure to the bladder through the catheter for a period of time sufficient to treat stage 3, stage 4, and/or stage 5 chronic kidney disease.
Item 109: a ureteral catheter, comprising: a drainage lumen comprising a proximal portion configured to be positioned in at least a portion of a patient's urethra and a distal portion configured to be positioned in a patient's ureter and/or kidney, the distal portion comprising a coiled retention portion comprising: at least one first coil having a first diameter; at least one second coil having a second diameter, the first diameter being smaller than the second diameter; and one or more perforations in the side wall of the fluid conducting lumen that allow fluid to flow into the fluid conducting lumen, wherein a portion of the fluid conducting lumen that is proximal to the retention portion defines a straight or curved central axis prior to insertion into the urinary tract of the patient, and wherein the first coil and the second coil of the retention portion extend around an axis of the retention portion that is at least partially coextensive with the straight or curved central axis of the portion of the fluid conducting lumen when deployed.
Item 110: the ureteral catheter of item 109, wherein the axis of the retention portion is arcuate with respect to the central axis of the fluid lumen.
Item 111: the ureteral catheter of item 109 or 110, wherein at least a portion of the axis of the retention portion extends at an angle ranging from about 15 degrees to about 75 degrees from the central axis.
Item 112: the ureteral catheter of any of claims 109-111, wherein the catheter is convertible between a contracted shape for insertion into a patient ureter and a deployed shape for deployment within the ureter.
Item 113: the ureteral catheter of any of claims 109-112, wherein the retention portion further comprises a third coil extending about the axis of the retention portion, the third coil having a diameter that is greater than or equal to the first diameter or the second diameter.
Item 114: the ureteral catheter of any of claims 109-113, wherein the retention portion of the drainage lumen comprises a sidewall comprising a radially inward side and a radially outward side, and wherein the total surface area of the radially inward perforations is greater than the total surface area of the radially outward upward perforations.
Item 115: the ureteral catheter according to any of claims 109-114, wherein the retention portion of the drainage lumen comprises a sidewall comprising a radially inward side and a radially outward side, and wherein the one or more perforations are located radially inward, and wherein the radially outward side is substantially free of perforations.
Item 116: the ureteral catheter of any of claims 109-116, wherein the drainage lumen is formed at least in part from one or more of copper, silver, gold, nitinol, stainless steel, titanium, polyurethane, polyvinylchloride, polytetrafluoroethylene (PTFE), latex, and silicone.
Item 117: the ureteral catheter of any of claims 109-116, wherein the retention portion of the catheter further comprises an open distal end for allowing fluid to flow into the catheter.
Item 118: the ureteral catheter of any of claims 109-117, wherein each of the one or more perforations has a diameter of about 0.7-0.9 mm.
Item 119: the ureteral catheter of any of claims 109-118, wherein the first diameter is about 8mm-10mm and the second diameter is about 16mm-20mm.
Item 120: a system for introducing negative pressure into a portion of a patient's urinary tract, the system comprising: at least one urine collection catheter includes a drainage lumen comprising a proximal portion configured to be positioned in at least a portion of a patient's urethra and a distal portion configured to be positioned in a patient's ureter and/or kidney, the distal portion comprising a coiled retention portion comprising: at least one first coil having a first diameter; at least one second coil having a second diameter, the first diameter being smaller than the second diameter; allowing fluid to flow into one or more perforations in a side wall of the fluid conducting lumen, wherein a portion of the fluid conducting lumen that is proximal to the retention portion defines a straight or curved central axis prior to insertion into the urinary tract of the patient, and wherein the first coil and the second coil of the retention portion extend about an axis of the retention portion that is at least partially coextensive with the straight or curved central axis of the portion of the fluid conducting lumen when deployed; and a pump in fluid communication with the drainage lumen of the at least one ureteral catheter, the pump configured to introduce negative pressure into a portion of the patient's urinary tract to aspirate fluid through the drainage lumen of the ureteral catheter.
Item 121: the system of clause 120, further comprising: one or more sensors in fluid communication with the fluid conducting chambers, the one or more sensors configured to determine information including at least one of capacitance, analyte concentration, and temperature of urine within each fluid conducting chamber; and a controller comprising a computer readable memory including programming instructions that, when executed, cause the controller to: information from the one or more sensors is received and an operating parameter of the pump is adjusted to increase or decrease a vacuum pressure in the lumen of the at least one ureteral catheter to regulate the flow of urine through the lumen based at least in part on the information received from the one or more sensors.
Item 122: the system of clause 120 or 121, further comprising a data transmitter in communication with the controller, the data transmitter configured to provide information from the one or more sensors to an external source.
Item 123: the system of any one of claims 120-122, wherein the pump provides a sensitivity of 10mmHg or less.
Item 124: the system of any of claims 120-122, wherein the pump is configured to alternate between providing a negative pressure and providing a positive pressure.
Item 125: the system of clause 124, wherein a negative pressure in the range of 5mmHg to 50mmHg is provided, and wherein a positive pressure in the range of 5mmHg to 20mmHg is provided.
Item 126: a method of inhibiting kidney injury by applying negative pressure to reduce interstitial pressure within the tubules of the medullary area to promote urine drainage and prevent venous congestion-induced nephron hypoxia in the renal medullary, the method comprising: deploying a ureteral catheter in a ureter and/or a kidney of a patient such that flow of urine from the ureter and/or kidney is not prevented by the deployment catheter blocking the ureter and/or kidney; and applying negative pressure to the ureter and/or the kidney through the catheter for a period of time sufficient to facilitate urine drainage from the kidney, wherein the ureter catheter comprises a drainage lumen comprising a proximal portion configured to be positioned in at least a portion of a patient's urethra and a distal portion configured to be positioned in the patient's ureter and/or kidney, the distal portion comprising a coiled retention portion comprising: at least one first coil having a first diameter; at least one second coil having a second diameter, the first diameter being smaller than the second diameter; and one or more perforations in the side wall of the catheter that allow fluid to flow into the catheter, wherein a portion of the catheter that is the proximal end of the retention portion defines a straight or curved central axis prior to deployment, and wherein the first coil and the second coil of the retention portion extend around an axis of the retention portion that is at least partially coextensive with the straight or curved central axis of the portion of the catheter when deployed.
Item 127: the method of item 126, further comprising, upon application of negative pressure to the ureter and/or kidney, drawing urine into the drainage lumen by drawing the urine through the one or more perforations, thereby altering interstitial pressure within the patient's kidney.
Item 128: the method of clause 126 or 127, wherein applying negative pressure to the ureter and/or kidney through the catheter is provided for a period of time sufficient to treat acute kidney injury caused by venous congestion.
Brief Description of Drawings
These and other features and properties of the present disclosure, as well as the methods of operation and the functional and manufacturing economies of manufacture of the related elements of structure, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention.
Further features and other examples and advantages will become apparent from the following detailed description with reference to the accompanying drawings,
wherein:
FIG. 1 is a schematic illustration of an indwelling portion of a urine collection assembly deployed in a urinary tract of a patient according to an embodiment of the present invention;
Fig. 2A is a perspective view of an example ureteral catheter according to the present disclosure;
fig. 2B is an elevation view of the ureteral catheter of fig. 2A;
fig. 3A is a schematic view of one example of a retention portion of an example ureteral catheter according to the present invention;
fig. 3B is a schematic view of another example of a retention portion of an example ureteral catheter according to the present invention;
fig. 3C is a schematic view of another example of a retention portion of an example ureteral catheter according to the present invention;
fig. 3D is a schematic view of another example of a retention portion of an example ureteral catheter according to the present invention;
fig. 3E is a schematic view of another example of a retention portion of an example ureteral catheter according to the present invention;
fig. 4A is a schematic view of another example of a retention portion of an example ureteral catheter according to the present invention;
FIG. 4B is a schematic illustration of a cross-sectional view of a portion of the retention portion of FIG. 4A taken along line B-B of FIG. 4A;
fig. 5A is a schematic view of another example of a retention portion of an example ureteral catheter according to the present invention;
FIG. 5B is a schematic diagram of a cross-sectional view of a portion of the retention portion of FIG. 5A taken along line B-B of FIG. 5A;
Fig. 6 is a schematic view of another example of a retention portion of an example ureteral catheter according to the present invention;
fig. 7 is a schematic view in cross-section of another example of a retention portion of an example ureteral catheter according to the present invention;
fig. 8 is a schematic view of another example of a retention portion of an example ureteral catheter according to the present invention;
FIG. 9A is a schematic view of another example of a urine collection assembly according to an example of the invention;
FIG. 9B is a partial schematic view taken along section 9B-9B of the bladder fluke portion of the assembly of FIG. 9A;
FIG. 10A is a schematic view of another example of a urine collection assembly according to an example of the invention;
FIG. 10B is a schematic view taken along section 10B-10B of the bladder fluke portion of the assembly of FIG. 10A;
FIG. 11A is a schematic view of an example urine collection assembly according to the present invention;
FIG. 11B is a schematic view taken along section 11B-11B of the bladder fluke portion of the assembly of FIG. 11A;
FIG. 12A is a schematic view of another bladder fluke portion of an example urine collection assembly according to the present disclosure;
FIG. 12B is a schematic view of a cross-section of a bladder catheter of the urine collection assembly taken along line C-C of FIG. 12A;
FIG. 12C is a schematic diagram of a cross-section of another example of a bladder catheter of the urine collection assembly;
FIG. 13 is a schematic view of another example of a bladder fluke portion of an example urine collection assembly according to the present disclosure;
FIG. 14 is a schematic view of another example of a bladder fluke portion of an example urine collection assembly according to the present disclosure;
FIG. 15 is a schematic view of another example of a bladder fluke portion of a urine collection assembly configured to be deployed in a patient's bladder and urethra in accordance with one example of the invention;
FIG. 16 is a schematic view of another example of a bladder fluke portion of an example urine collection assembly according to the invention;
FIG. 17A is an exploded perspective view of a connector of an example urine collection assembly according to the present disclosure;
FIG. 17B is a cross-sectional view of a portion of the connector of FIG. 17A;
FIG. 17C is a schematic view of a connector of an example urine collection assembly according to the present disclosure;
fig. 18A is a flow chart illustrating a process of inserting and deploying a ureteral catheter or a urine collection assembly, according to an example of the present invention;
fig. 18B is a flow chart illustrating a process of applying negative pressure using a ureteral catheter or a urine collection assembly, according to one example of the present invention;
FIG. 19 is a schematic diagram of a system for introducing negative pressure into a patient's urinary tract in accordance with an example of the invention;
FIG. 20A is a plan view of a pump for use with the system of FIG. 19 in accordance with an example of the present invention;
FIG. 20B is a side view of the pump of FIG. 20A;
FIG. 21 is a schematic of an experimental setup for evaluating negative pressure therapy in a pig model;
FIG. 22 is a graph of creatinine clearance for the experiment conducted with the experimental setup shown in FIG. 21;
FIG. 23A is a low magnification micrograph of kidney tissue from a congested kidney treated with negative pressure therapy;
FIG. 23B is a high magnification photomicrograph of the kidney tissue shown in FIG. 23A;
FIG. 23C is a low magnification micrograph of kidney tissue from a engorged and untreated (e.g., control) kidney; and
fig. 23D is a high magnification micrograph of the kidney tissue shown in fig. 23C.
Detailed Description
As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.
The terms "right", "left", "upper" and derivatives thereof as used herein may be related to the present invention due to the orientation of the terms in the drawings. The term "proximal" refers to the portion of the catheter device that is manipulated or contacted by the user and/or to the portion of the indwelling catheter that is closest to the urinary tract entry site. The term "distal" refers to the opposite end of a catheter device configured to be inserted into a patient and/or to the portion of the device that is inserted furthest into the patient's urinary tract. However, it is to be understood that the invention may assume various alternative orientations and, accordingly, such terms are not to be considered as limiting. Moreover, it is to be understood that the invention may assume various alternative variations and step sequences, except where expressly specified to the contrary. It is to be further understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification are examples. Accordingly, the specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.
For the purposes of this specification, unless otherwise indicated, all numbers expressing quantities of ingredients, reaction conditions, scales, physical properties, and so forth used in the specification and claims are to be understood as being modified in all instances by the term "about". Unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention.
Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
Furthermore, it should be understood that any numerical range recited herein is intended to include all sub-ranges subsumed therein. For example, a range of "1-10" is intended to include any and all subranges between the minimum value of 1 recited and the maximum value of 10 recited and to include the minimum value of 1 recited and the maximum value of 10 recited, i.e., all subranges beginning with a minimum value equal to or greater than 1 and ending with a maximum value of equal to or less than 10, and all subranges therebetween, such as 1 to 6.3, or 5.5 to 10, or 2.7 to 6.1.
The terms "communicate" and "communicate with … …" as used herein refer to the receipt or transmission of one or more signals, information, instructions, or other data types. By a unit or component in communication with another unit or component is meant that the unit or component is capable of directly or indirectly receiving data from and/or transmitting data to the other unit or component. This may refer to a direct or indirect connection that may be wired and/or wireless in nature. Alternatively, two units or components may communicate with each other, but the data transferred may be modified, processed, or sent between the first and second units or components, etc. For example, a first unit may communicate with a second unit, but the first unit passively receives data and does not actively transmit data to the second unit. As another example, a first unit may communicate with a second unit, although an intermediate unit processes data from one unit and transmits the processed data to the second unit. It should be appreciated that a variety of other arrangements are possible.
Fluid retention and venous congestion are the primary problems in the progression of end stage renal disease. The relative decrease in excess sodium intake plus excretion results in isotonic volume expansion and secondary compartment involvement. In some examples, the present invention relates generally to devices and methods for facilitating the drainage of urine or waste from a patient's bladder, ureter, and/or kidney. In some examples, the present invention relates generally to devices and methods for introducing negative pressure into the bladder, ureter, and/or kidney of a patient. While not wishing to be bound by any theory, it is believed that applying negative pressure to the bladder, ureters, and/or kidneys may in some cases counteract sodium and water medullary nephron tubule reabsorption. Counteracting reabsorption of sodium and water increases urine production, reduces total sodium in the body, and increases erythrocyte production. Since the intramedullary pressure is driven by sodium, the volume is overloaded and the directional removal of excess sodium enables maintenance of the volume loss. Removal of volume restores medullary homeostasis (hemostasis). Normal urine production is 1.48-1.96L/day (or 1-1.4 ml/min).
Fluid retention and venous congestion are also the primary problems in the progression of prerenal Acute Kidney Injury (AKI). In particular, AKI may be associated with perfusion through the kidney or loss of blood flow. Thus, in some examples, the invention promotes renal hemodynamic improvement and increases urine output for the purpose of relieving or alleviating venous congestion. Furthermore, treatment and/or inhibition of AKI is expected to positively affect and/or reduce the occurrence of other conditions, e.g., to reduce or inhibit worsening renal function in patients with NYHA class III and/or IV heart failure. Classification of different levels of heart failure is described in The Criteria Committee of the New York Heart Association, (1994),Nomenclature and Criteria for Diagnosis of Diseasesof the Heart and Great Vessels,(9th ed.),Boston:Little,Brown&co.pp.253-256, the disclosure of which is incorporated herein by reference in its entirety. The reduction or inhibition of the onset of AKI and/or the reduction in long-term perfusion may also be stage 4 and/orTreatment of stage 5 chronic kidney disease. Chronic kidney disease progression is described in National Kidney Foundation, K/DOQI Clinical Practice Guidelines for Chronic Kidney Disease:evaluation, classification and construction.am.j. Kidney dis.39:s1-S266,2002 (suppl.1), the disclosure of which is incorporated herein by reference in its entirety.
Referring to fig. 1, the urinary tract contains the right kidney 2 and left kidney 4 of the patient. As described above, kidneys 2, 4 are responsible for hemofiltration and clearance of waste compounds from the body via urine. Urine produced by the right kidney 2 and left kidney 4 flows into the patient's bladder 10 through the tubules, right ureter 6 and left ureter 8. For example, urine may be conducted through ureters 6, 8 by peristaltic movement of the ureter walls and by gravity. The ureters 6, 8 enter the bladder 10 via ureter holes or ports 16. Bladder 10 is flexible and is a substantially hollow structure adapted to collect urine until the urine is excreted from the body. Bladder 10 may be converted from an empty position (represented by reference line E) to a full position (represented by reference line F). Typically, when the bladder 10 reaches a substantially full condition, urine is allowed to flow from the bladder 10 into the urethra 12 through the urethral sphincter muscle or orifice 18 located in the lower portion of the bladder 10. The contraction 10 of the bladder may react to stresses and pressures applied to the trigones 14 of the bladder 10, which are the trigones extending between the ureteral orifice 16 and the urethral orifice 18. The triangle 14 is sensitive to stress and pressure such that when the bladder 10 begins to fill, the pressure on the triangle 14 increases. When the threshold pressure on the triangle 14 is exceeded, the bladder 10 begins to contract to drain the collected urine through the urethra 12.
Exemplary ureteral catheter:
as shown in fig. 1, a urine collection assembly 100 is illustrated that includes ureteral catheters 112, 114 configured to be positioned within a patient's urinary tract. For example, the distal ends 120, 121 of the ureteral catheters 112, 114 may be configured to be deployed at the ureters 2, 4 of the patient, particularly at the regions 20, 21 of the renal pelvis of the kidneys 6, 8.
In some examples, urine collection assembly 100 may include two separate ureteral catheters, such as a first catheter 112 placed in or near renal pelvis 20 of right kidney 2 and a second catheter 114 placed in or near renal pelvis 21 of left kidney 4. The conduits 112, 114 may be separate throughout their length, or may be held in proximity to each other by clips, rings, clamps, or other types of connection mechanisms (e.g., connector 150) to facilitate placement or removal of the conduits 112, 114. In some examples, the conduits 112, 114 may merge or join together to form a single drainage lumen. In other examples, the catheters 112, 114 may be inserted into or enclosed within another catheter, tube, or sheath along portions or sections thereof to facilitate insertion and withdrawal of the catheters 112, 114 from the body. For example, the urinary bladder catheter 116 can be inserted over and/or along the same guide wire as the ureteral catheters 112, 114, thus extending the ureteral catheters 112, 114 from the distal end 116 of the urinary bladder catheter.
Referring to fig. 1, 2A and 2B, an exemplary ureteral catheter 112 may include at least one elongate body or tube 122 that defines or contains one or more fluid-guiding channels or lumens, such as a fluid-guiding lumen 124, therein. Tube 122 may range in size from about 1Fr to about 9Fr (flanged western catheter scale). In some examples, tube 122 may have an outer diameter ranging from about 0.33 to about 3mm and an inner diameter ranging from about 0.165 to about 2.39 mm. In a preferred example, tube 122 is 6Fr and has an outer diameter of 2.0±0.1 mm. The length of tube 122 may range from about 30cm to about 120cm, depending on the age (e.g., pediatric or adult) and sex of the patient.
The tube 122 may be formed of a flexible and/or deformable material to facilitate advancement and/or placement of the tube 122 into the bladder 10 and ureters 6, 8 (shown in fig. 1). The catheter material should be flexible and soft to avoid or mitigate irritation of the renal pelvis and ureter, but sufficiently rigid that the tube 122 does not collapse when pressure is applied to the exterior of the tube 122 by the renal pelvis or other parts of the urinary tract, or when the renal pelvis and/or ureter is inhaled against the tube 122 during the introduction of negative pressure. For example, tube 122 may be formed of a biocompatible polymer, polyvinyl chloride, polytetrafluoroethylene (PTFE), for example A silicon latex or a silicon-containing material. In a preferred embodiment, tube 122 is formed from thermoplastic polyurethane. At least a portion or all of the conduit 112, e.g., tube 122, may be coatedHydrophilic coatings are applied to facilitate insertion and/or removal, and/or to enhance comfort. In some examples, the coating is a hydrophobic and/or lubricious coating. For example, suitable coatings may include +.>Hydrophilic coatings (available from Koninklijke DSM n.v.) or polyelectrolyte-containing hydrophilic coatings such as disclosed in U.S. patent No. 8,512,795 (incorporated herein by reference).
In some examples, tube 122 may include: distal portion 118 (e.g., a portion of tube 122 configured to be placed in ureters 6, 8 and renal pelvis 20, 21); an intermediate portion 126 (e.g., a portion of tube 122 configured to extend from the distal portion through ureteral orifice 16 into patient's bladder 10 and urethra 12); and a proximal portion 128 (e.g., a portion of tube 122 extending from urethra 12 to an external fluid collection reservoir and/or pump assembly). In a preferred example, the combined length of proximal portion 128 and intermediate portion 126 of tube 122 is about 54±2cm. In some examples, tube 122 terminates in another indwelling catheter and/or a drainage lumen, such as drainage lumen 116 of a bladder catheter. In this case, fluid is expelled from the proximal end of the ureteral catheter 112, 114 and is directed from the body through additional indwelling catheters and/or catheter lumens.
Exemplary ureter retention portion:
with continued reference to fig. 1, 2A and 2B, the distal portion 118 of the ureteral catheter 112 includes a retention portion 130 for holding the distal end 120 of the catheter 112 in proximity to or at a desired fluid collection location within the renal pelvis 20, 21 of the kidneys 2, 4. In some examples, the retention portion 130 is configured to be flexible and bendable to allow placement of the retention portion 130 in the ureter and/or renal pelvis. The retention portion 130 is suitably sufficiently curved to absorb the forces exerted on the catheter 112 and prevent the forces from being transferred to the ureter. For example, if the retention portion 130 is pulled in a proximal direction P (shown in fig. 3A) toward the patient's bladder, the retention portion 130 may be flexible enough to begin to unravel or straighten so that it can be withdrawn through the ureter. Similarly, when the retention portion 130 can be reinserted into the renal pelvis or other suitable area within the ureter, it can tend to return to its expanded shape.
In some examples, the retention portion 130 is integral with the tube 122. In this case, the retention portion 130 may be formed by bending or crimping the sized and shaped catheter body 122 to hold the catheter at the desired fluid collection location. Suitable bends or coils may include coiled coils, helical coils, and/or spiral coils. For example, the retention portion 130 may include one or more radially and longitudinally extending helical coils configured to contact and passively retain the catheter 112 within the ureters 6, 8 proximate or within the renal pelvis 20, 21. In other examples, the retention portion 130 is formed with a radially flared or tapered portion of the catheter body 122. For example, the retention portion 130 may further include a fluid collection portion, such as a tapered or funnel-shaped inner surface 186, as shown in fig. 4A and 4B. In other examples, the retention portion 130 may include a separate element that is connected to the catheter body or tube 122 or that extends from the catheter body or tube 122.
The retention portion 130 may further include one or more perforated portions, such as a weep hole or port 132 (shown in fig. 3A-3E). The ports may be located, for example, at the open distal ends 120, 121 of the tubes 122. In other examples, the perforated portion and/or the port 132 are disposed along a sidewall of the distal portion 118 of the catheter 122. The liquid-guiding port or hole may be used to assist in fluid collection. In other examples, the retention portion 130 is the only retention structure and provides negative pressure for fluid collection and/or supply through structures elsewhere in the conduit 122.
Referring now to fig. 2A, 2B and 3A-3E, an exemplary retention portion 130 is illustrated that includes a plurality of helical coils, such as one or more complete coils 184 and one or more half coils or partial coils 183. The retention portion 130 is movable between a retracted position and an extended position having a plurality of helical coils. For example, a substantially straight wire may be inserted through the retention portion 130 to maintain the retention portion 130 in a substantially straight contracted position. When the wire is removed, the retention portion 130 may transition to its coiled shape. In some examples, coils 183, 184 extend radially and longitudinally from distal portion 118 of tube 122. Referring specifically to fig. 2A and 2B, in a preferred exemplary embodiment, the retention portion 130 comprises 2 full coils 184 and 1 half coil 183. The outside diameter of the completed coil 184, shown with line D1, may be about 18±2mm. Half coil 183 diameter D2 may be about 14mm. The height H of the coiled retention portion 130 is about 16±2mm. The retention portion 130 may further include one or more weep holes 132 (shown in fig. 3A-3E) configured to draw fluid into the interior of the conduit 122. In some examples, the retention portion 130 may include 6 weep holes, plus an additional hole in the distal tip 120 of the retention portion. The diameter of each of the weep holes 132 (shown in FIGS. 3A-3E) may range from about 0.7mm to about 0.9mm, preferably about 0.83.+ -. 0.01mm. The distance between adjacent weep holes 132, and specifically the linear distance between weep holes 132, may be about 22.5 + 2.5mm when the coil is straightened.
In another exemplary embodiment, as shown in fig. 3A-3E, the distal portion 118 of the catheter lumen proximal of the retention portion 130 defines a straight or curved central axis L. In some examples, at least one half coil or first coil 183 and a full coil or second coil 184 of the retention portion 130 extend about the axis a of the retention portion 130. The first coil 183 opens or begins at a point where the tube 122 is bent at an angle α (as shown by angle α) ranging from about 15 degrees to about 75 degrees from the central axis L, preferably about 45 degrees. As shown in fig. 3A and 3B, the axis a may be coextensive with the longitudinal central axis L prior to insertion into the body. In other examples, as shown in fig. 3C-3E, the axis a extends from the central longitudinal axis L and is bent or angled with respect to the central longitudinal axis L, e.g., angle β, prior to insertion into the body.
In some examples, the plurality of coils 184 may have the same inner and/or outer diameter D and height H2. In this case, the outer diameter D1 of the coil 184 may range from 10mm to 30mm. The height H2 between coils 184 may be about 3mm-10mm.
In other examples, the retention portion 130 is configured to be inserted into a tapered portion of the renal pelvis. For example, the outer diameter D1 of the coil 184 may increase with the distal end 120 of the tube 122, resulting in a helical structure having a tapered or partially tapered shape. For example, the distal or maximum outer diameter D1 of the tapered helical portion may range from about 10mm to about 30mm, which corresponds to the size of the renal pelvis. The height H2 of the retention portion 130 ranges from about 10mm to about 30mm.
In some examples, the outer diameter D1 and/or the height H2 of the coil 184 may vary in a regular or irregular manner. For example, the outside diameter D1 of the coils or the height H2 between coils may be increased or decreased by a regular amount (e.g., about 10% to about 25% between adjacent coils 184). For example, for a retention portion 130 having 3 coils (such as shown in fig. 3A and 3B), the outer diameter D3 of the proximal-most coil or first coil 183 may be about 6mm-18mm, the outer diameter D2 of the intermediate coil or second coil 185 may be about 8 mm-about 24mm, and the outer diameter D1 of the distal-most or third coil 187 may be between about 10mm and about 30 mm.
The retention portion 130 may further include a liquid-guiding port 132 or hole disposed on or in a sidewall of the conduit 122 at or near the retention portion 130 to allow urine waste to flow from the outside of the conduit 122 to the inside of the conduit 122. The position and size of the port 132 may vary depending on the desired flow rate and shape of the retention feature. The diameter of the port 132 may range from about 0.005mm to about 1.0mm. The spacing between the vents 132 may range from about 1.5mm to about 5mm. The ports 132 may be spaced apart in any arrangement, such as linear or offset. In some examples, the liquid transfer port 132 may be non-circular and may have a surface area of about.00002-0.79 mm 2 。
In some examples, as shown in fig. 3A, the drainage port 132 is located around the entire periphery of the sidewall of the conduit 122 to increase the amount of fluid that can flow into the drainage lumen 124 (shown in fig. 1, 2A, and 2B). In other examples, as shown in fig. 3B-3E, the ports 132 may be substantially only or only disposed radially inward of the coils 184 to prevent the ports 132 from clogging or blocking, and the outward facing sides of the coils may be substantially free of ports 132 or free of ports 132. For example, when negative pressure is introduced into the ureter and/or renal pelvis, the mucosal tissue of the ureter and/or kidney may inhale against the retention portion 130 and may occlude some of the fluid ports 132 on the periphery of the retention portion 130. When the tissue contacts the periphery of the retention portion 130, the fluid port 132 located radially inward of the retention feature will not become significantly blocked. In addition, the risk of tissue damage due to pinching or contact with the port 132 may be reduced or improved.
Referring to fig. 3C and 3D, other examples of ureteral catheters 112 having a retention portion 130 comprising a plurality of coils are illustrated. As shown in fig. 3C, the retention portion 130 includes 3 coils 184 extending around the axis a. Axis a is a curved arc extending from the central longitudinal axis L of the portion of the catheter lumen 181 proximal to the retention portion 130. The curvature imparted to the retention portion 130 may be selected to conform to the curvature of the renal pelvis (which comprises a sheep-angled cavity).
In another exemplary embodiment, as shown in fig. 3D, the retention portion 130 may comprise 2 coils 184 extending about an angled axis a. The angled axis a extends at an angle from the central longitudinal axis L and is angled relative to an axis generally perpendicular to the central axis L of the catheter portion, as indicated by β. The angle β may range from about 15 to about 75 degrees (e.g., about 105 to about 165 degrees relative to the central longitudinal axis L of the catheter 112 lumen portion).
Fig. 3E shows another example of ureteral catheter 112. The retention portion includes 3 helical coils 184 extending about axis a. The axis a is at an angle relative to the horizontal, as indicated by angle β. As with the previous examples, the angle β may range from about 15 to about 75 degrees (e.g., from about 105 to about 165 degrees relative to the central longitudinal axis L of the catheter 112 lumen portion).
Referring to fig. 4A and 4B, in another example, the retention portion 130 of the ureteral catheter 112 includes a catheter 122 having a widened and/or tapered distal portion, which in some examples is configured to be placed in the renal pelvis and/or kidney of a patient. For example, the retention portion 130 may be a funnel-shaped structure including an outer surface 185 configured to rest against the ureter and/or kidney wall, and including an inner surface 186 configured to direct fluid toward the drainage lumen 124 of the catheter 112. The retention portion 130 may include a proximal end 188 adjacent the distal end of the drainage lumen 124 and having a first diameter D1 and a distal end 190 having a second diameter D2 that is greater than the first diameter D1 when the retention portion 130 is in its deployed position. In some examples, the retention portion 130 is convertible from a collapsed or compressed position to an expanded position. For example, the retention portion 130 may be biased radially outward such that the retention portion 130 (e.g., funnel portion) expands radially outward into an expanded state as the retention portion 130 is advanced toward its fluid collection position.
The retention portion 130 of the ureteral catheter 112 may be made of a variety of suitable materials that are capable of transitioning from a collapsed state to an expanded state. In one example, the retention portion 130 comprises a framework of tines or elongate members formed from a temperature-sensitive shape memory material (e.g., nitinol). In some examples, the nitinol frame may be covered with a suitable waterproof material (e.g., silicon) to form a tapered portion or funnel. In this case, fluid is allowed to flow down along the inner surface 186 of the retention portion 130 and into the drip chamber 124. In other examples, the retention portion 130 is formed from a different rigid or partially rigid plate or material that is bent or molded to form a funnel-shaped retention portion as shown in fig. 4A and 4B.
In some examples, the retention portion of the ureteral catheter 112 may include one or more mechanical stimulation devices 191 for providing stimulation to nerve and muscle fibers in adjacent tissue of the ureter and renal pelvis. For example, the mechanical stimulation device 191 may comprise a linear or annular actuator embedded or mounted near a portion of the sidewall of the conduit 122 and configured to emit low-level vibrations. In some examples, mechanical stimulation may be provided to the ureter and/or a portion of the renal pelvis to supplement or modify the therapeutic effect obtained by the application of negative pressure. Without being bound by theory, it is believed that such stimulation affects adjacent tissue by, for example, stimulating nerves and/or initiating peristaltic muscles associated with the ureter and/or renal pelvis. Stimulation of nerves and activation of muscles can create pressure gradients or changes in pressure levels in surrounding tissues and organs, which can help or in some cases enhance the therapeutic benefits of negative pressure therapy.
Referring to fig. 5A and 5B, according to another example, the retention portion 330 of the ureteral catheter 312 includes a catheter 322 having a distal portion 318 formed in a spiral structure 332 and an inflatable element or balloon 350 positioned proximal to the spiral structure 332 to provide an additional degree of retention at the renal pelvis and/or fluid collection site. Balloon 350 may be inflated to a pressure sufficient to retain the balloon in the renal pelvis or ureter, but low enough to avoid inflation or damage to these structures. Suitable inflation pressures are known to those skilled in the art and are readily identified by trial and error. As in the previous example, the helical structure 332 may be provided by bending the conduit 322 to form one or more coils 334. The coil 334 may have a constant or variable diameter and height as described above. Catheter 322 further includes a plurality of drainage ports 336 positioned in a side wall of catheter 322 to allow urine to be drawn into drainage lumen 324 of catheter 322 and to direct urine from within the body through, for example, medial and/or lateral drainage lumens 324 of coil 334.
As shown in fig. 5B, the inflatable element or balloon 350 may comprise an annular balloon-like structure having, for example, a generally heart-shaped cross-section and including a surface or cover 352 defining a cavity 353. Lumen 353 is in fluid communication with inflation lumen 354 which extends parallel to the drainage lumen 324 defined by conduit 322. Balloon 350 may be configured to be inserted into the tapered portion of the renal pelvis and inflated such that its outer surface 356 contacts and rests against the ureter and/or the inner surface of the renal pelvis. The inflatable element or balloon 350 may include a tapered inner surface 358 that extends longitudinally and radially inwardly toward the catheter 322. The inner surface 358 may be configured to direct urine toward the catheter 322 for aspiration into the catheter lumen 324. The inner surface 358 may also be positioned to prevent fluid from accumulating in the ureter, for example, at the periphery of the inflatable element or balloon 350. The inflatable retention portion or balloon 350 is suitably sized to fit within the renal pelvis and may have a diameter ranging from about 10mm to about 30 mm.
Referring to fig. 6 and 7, in some examples, an assembly 400 including a ureteral catheter 412 including a retention portion 410 is illustrated. The retention portion 410 is formed from a porous and/or sponge-like material that is coupled to the distal end 421 of the catheter 422. The porous material may be configured to channel and/or absorb urine and direct the urine to the drainage lumen 424 of the catheter 422. As shown in fig. 7, the retention portion 410 may be a porous wedge-shaped structure configured to be inserted and retained in a patient's renal pelvis. The porous material comprises a plurality of openings and/or channels. Fluid may be drawn through the channels and openings, such as by gravity or upon introduction of negative pressure through the conduit 412. For example, fluid may enter wedge-shaped retention portion 410 through an orifice and/or channel and be drawn toward distal port 420 of liquid-guiding chamber 424 by, for example, capillary action, peristaltic action, or as a result of introducing negative pressure into the orifice and/or channel. In other examples, as shown in fig. 7, the retention portion 410 comprises a hollow funnel structure formed from a porous sponge-like material. As indicated by arrow a, fluid is directed down an inner surface 426 of the funnel structure into a drainage lumen 424 defined by conduit 422. In addition, fluid may enter the funnel structure of the retention portion 410 through holes and channels in the porous sponge-like material of the side wall 428. For example, suitable porous materials may include open cell polyurethane foams, such as polyurethane ethers. Suitable porous materials may also include materials comprising, for example, polyurethane, silicone, polyvinyl alcohol, cotton, or polyester; laminates of woven or nonwoven layers with or without antimicrobial additives such as silver and with or without additives that improve material properties such as hydrogels, hydrocolloids, acrylics, or silicones.
Referring to fig. 8, according to another example, the retention portion 500 of the ureteral catheter 512 includes an expandable cage 530. The expandable cage 530 includes one or more longitudinally and radially extending hollow tubes 522. For example, tube 522 may be formed from a resilient shape memory material (e.g., nitinol). Cage 530 is configured to transition from a contracted state for insertion through the patient's urinary tract to a deployed state for placement in the patient's ureter and/or kidney. The hollow tube 522 includes a plurality of fluid guides 534 that may be disposed in the tube, such as radially inward thereof. The ports 534 are configured to allow flow or suction through the ports 534 and into the respective tubes 522. Fluid is discharged through the hollow tube 522 into the drainage lumen 524 defined by the catheter body 526 of the ureteral catheter 512. For example, the fluid may flow along a path represented by arrow 532 in fig. 8. In some examples, when negative pressure is introduced into the renal pelvis, kidneys, and/or ureter, the ureter wall and/or portions of the renal pelvis may inhale against the surface of the outward surface of the hollow tube 522. The stoma 534 is positioned and configured so as not to become appreciably blocked by ureteral structures when negative pressure is applied to the ureter and/or kidney.
Exemplary urine collection assembly:
Referring now to fig. 1, 9A and 11A, the urine collection assembly 100 further includes a bladder catheter 116. The distal ends 120, 121 of the ureteral catheters 112, 114 may be connected to the bladder catheter 116 to provide a single drainage lumen for urine, or the ureteral catheters may be expelled from the bladder catheter 116 through separate tubes.
Exemplary bladder catheter
Bladder catheter 116 includes a deployable closed end and/or anchor hook 136 for anchoring, retaining, and/or providing passive securement of the indwelling portion of urine collection assembly 100, and in some examples, preventing premature and/or negligible removal of the assembly components during use. The anchor hook 136 is configured to be positioned near the lower wall of the patient's bladder 10 (shown in fig. 1) to prevent patient activity and/or forces exerted on the indwelling catheters 112, 114, 116 from being conducted to the ureters. Bladder catheter 116 includes a liquid guide lumen 140 (shown in fig. 19) defined therein that is configured to direct urine from bladder 10 into an external urine collection container 712. In some examples, the bladder catheter 116 may range in size from about 8Fr to about 24Fr. In some examples, bladder catheter 116 may have an outer diameter ranging from about 2.7 to about 8 mm. In some examples, bladder catheter 116 may have an inner diameter ranging from about 2.16 to about 6.2 mm. Different lengths of bladder catheter 116 may be obtained to accommodate anatomical differences in the gender and/or size of the patient. For example, the average female urethra length is only a few inches, so the length of tube 138 can be quite short. The average urethral length of a male is longer due to the penis and may be variable. It is possible that women may use bladder catheter 116 with longer tubing 138, so long as the lengthy tubing does not increase the difficulty of handling and/or preventing contamination of the sterile portion of catheter 116. In some examples, the sterile and indwelling portion of the bladder catheter 116 may range from about 1 inch to about 3 inches (for females) and about 20 inches for males. The overall length of the bladder catheter 116, including the sterile and non-sterile portions, may be 1 to several feet.
Catheter 138 may include one or more drainage ports 142 configured to be positioned in bladder 10 for drawing urine into drainage lumen 140. For example, excess urine remaining in the patient's bladder 10 during placement of the ureteral catheters 112, 114 is drained from the bladder 10 through the port 142 and the drainage lumen 140. In addition, any urine that is not collected by ureteral catheters 112, 114 accumulates in bladder 10 and may be drawn from the urinary tract through a drainage lumen 140. Negative pressure may be applied to the drainage lumen 140 to aid in fluid collection, or may be maintained at ambient pressure such that fluid is collected by gravity and/or as a result of partial contraction of the bladder 10. In some examples, the ureteral catheters 112, 114 may extend from the drainage lumen 140 of the bladder catheter 116 to facilitate and/or simplify insertion and placement of the ureteral catheters 112, 114.
With particular reference to fig. 1, the deployable closed end and/or the anchor hook 136 is disposed at or near the distal end 148 of the bladder catheter 116. The expandable fluke 136 is configured to transition between a contracted state and an expanded state for insertion into the bladder 10 through the urethra 12 and the urethra orifice 18. The anchor hook 136 is configured to be deployed under the bladder 10 and/or against and adjacent to the urethral meatus 18. For example, the anchor 136 may be placed near the urethral orifice 18 to enhance the suction of the negative pressure applied to the bladder 10, or to partially, substantially, or completely occlude the bladder 10 in the absence of negative pressure to ensure that urine in the bladder 10 is introduced through the drainage lumen 140 and prevented from leaking to the urethra 12. For bladder catheter 116 that includes 8Fr-24 Fr elongate tube 138, anchor 136 can be about 12Fr-32 Fr (e.g., having a diameter of about 4mm to about 10.7 mm) in the deployed state, preferably between about 24Fr and 30 Fr. The 24Fr fluke has a diameter of about 8 mm. It is contemplated that 24Fr fluke 136 will be a single size suitable for all or most patients. For a catheter 116 with a 24Fr fluke 136, a suitable length of fluke 136 is between about 1.0cm and 2.3cm, preferably about 1.9cm (about 0.75 in).
Exemplary bladder fluke structure:
with specific reference to fig. 1, 12A and 13, an exemplary bladder anchor hook 136 in the form of an expandable balloon 144 is illustrated. Expandable (e.g., inflatable) balloon 144 may be a balloon, such as a Foley catheter. Balloon 144 may have a diameter of about 1.0cm to about 2.3cm, with a diameter of about 1.9cm (0.75 in) being preferred. Balloon 144 is preferably made of a material including, for example, biocompatible polymers, polyvinyl chloride, polytetrafluoroethylene (PTFE), for exampleA silicone latex or a silicone flexible material.
The bladder 144 is in fluid communication with an inflation chamber 146 that is inflated by introducing fluid into the bladder 144. In the deployed state, the balloon 144 may be a generally spherical structure mounted on and extending radially outwardly from the catheter 138 of the bladder catheter 116 and containing a central lumen or passage for passage of the catheter 138. In some examples, the catheter 138 extends through a lumen defined by the balloon 144 such that the open distal end 148 of the catheter 138 extends distally of the balloon 144 and toward the center of the bladder 10 (shown in fig. 1). Excess urine collected in bladder 10 may be drawn into the drainage lumen 140 through its distal open end 148.
As shown in fig. 1 and 12A, in one example, ureteral catheters 112, 114 extend from an open distal end 148 of the catheter lumen 140. In another example, as shown in fig. 14, the ureteral catheters 112, 114 extend through a port 172 or mouth of the sidewall of the catheter 138 that is placed at a location distal to the balloon 144. The port 172 may be circular or oval. The port 172 is sized to receive the ureteral catheter 112, 114 and, thus, may have a diameter ranging from about 0.33mm to about 3 mm. As shown in FIG. 13, in another example, bladder catheter 116 is positioned alongside balloon 144, rather than extending through a central lumen defined by balloon 144. As in other examples, the ureteral catheters 112, 114 extend through the mouth 172 of the sidewall 116 of the bladder catheter and into the bladder 10.
Referring to fig. 12B, a cross-sectional view of the bladder catheter 116 and ureteral catheters 112, 114 is shown. As shown in FIG. 12B, in one example, bladder catheter 116 comprises a dual lumen catheter with a catheter lumen 140 in its central region and a smaller inflation lumen 146 extending along the periphery of catheter 138. Ureteral catheters 112, 114 are inserted or enclosed in a central drainage lumen 140. Ureteral catheters 112, 114 are single lumen catheters having a cross section that is sufficiently narrow to fit into a guidewire lumen 140. In some instances, as described above, the ureteral catheter 112, 114 extends through the entire bladder catheter 116. In other examples, ureteral catheters 112, 114 terminate in a drainage lumen 140 of bladder catheter 116, or at the site of patient ureter 12 or at an outer portion of drainage lumen 140. As shown in fig. 12C, in another example, bladder catheter 116a is a multi-lumen catheter defining at least 4 lumens, i.e., a first lumen 112A for directing fluid from first ureteral catheter 112 (shown in fig. 1), a second lumen 114a for directing fluid from second ureteral catheter 114 (shown in fig. 1), a third lumen 140a for draining urine from bladder 10 (shown in fig. 1), and an inflation lumen 146a for directing fluid from balloon 144 back and forth (shown in fig. 12A) for inflation and deflation thereof.
As shown in fig. 15, another example of a catheter balloon 144 for use with the urine collection assembly 100 is illustrated. In the example of fig. 15, balloon 144 is configured to be positioned partially within patient's bladder 10 and partially within urethra 12 to provide an enhanced bladder closure. The central portion 145 of the balloon 144 is configured to be radially contracted by the urethral orifice 18, thus defining a bulbous upper volume configured to be located in a lower portion of the bladder 10 and a bulbous lower volume located in a distal portion of the urethra 12. As in the previous examples, bladder catheter 116 extends through a central lumen defined by balloon 144 and toward the central portion of bladder 10, and includes a drainage port 142 that directs urine from bladder 10 through drainage lumen 140 of catheter 116. The port 142 may be generally circular or oval in shape and may have a diameter of about 0.005mm to about 0.5 mm.
Referring again to fig. 9A and 9B, another example of a urine collection assembly 100 including a bladder fluke device 134 is illustrated. Bladder fluke device 134 includes bladder conduit 116 defining a drainage lumen 140, an inflation lumen 146, and a fluke 136 (i.e., another example of an expandable balloon 144 configured to be positioned in a lower portion of bladder 10). Unlike the previous examples, the port 142 configured to receive the ureteral catheters 112, 114 is placed proximally of and/or under the balloon 144. Ureteral catheters 112, 114 extend from the port 142 and, as in the previous examples, through the ureteral opening or port of the bladder and into the ureter. When the anchor 136 is deployed in the bladder, the port 142 is placed in the lower portion of the bladder proximate the urethral meatus. Ureteral catheters 112, 114 extend from the mouth 172 and between the lower part of the balloon 144 and the bladder wall. In some examples, catheters 112, 114 may be placed to prevent balloon 144 and/or the bladder wall from occluding port 142 so that excess urine collected in the bladder may be drawn into suction port 142 for expulsion from the body.
Referring again to fig. 10A and 10B, in another example of a urine collection assembly 200, an expandable cage 210 anchors the assembly 200 in the bladder. The expandable cage 210 includes a plurality of flexible members 212 or tines extending longitudinally and radially outward from the catheter body 238 of the bladder catheter 216, which in some examples may be similar to those discussed in relation to the retention portion of the ureteral catheter of fig. 8. The member 212 may be formed from a suitable resilient and shape memory material (e.g., nitinol). In the deployed position, the member 212 or tines are given sufficient curvature to define a spherical or elliptical central cavity 242. The cage 210 is coupled to the open distal open end 248 of the catheter or catheter body 238 to allow access to the catheter lumen 240 defined by the tube or body 238. The cage 210 is sized for placement within the lower portion of the bladder and may enclose a diameter and length ranging from 1.0cm to 2.3cm, preferably about 1.9cm (0.75 in).
In some examples, the cage 210 further includes a cover or lid 214 over the distal portion of the cage 210 to prevent or reduce the likelihood that the tissue, i.e., the distal wall of the bladder, may become caught or pinched by contact with the cage 210 or member 212. More specifically, as the bladder contracts, the distal inner wall of the bladder contacts the distal side of the cage 210. The cover 214, which prevents tissue from being clamped or caught, may alleviate patient discomfort and protect the device during use. The cover 214 may be formed at least in part from a porous and/or permeable biocompatible material (e.g., a woven polymer mesh). In some examples, the cover 214 encloses all or substantially all of the cavity 242. In this case, the cover 214 defines a mouth adapted to receive the ureteral catheter 112, 114. In some examples, the cover 214 covers only about the distal 2/3, about the distal half, or about the distal third of the cage 210, or any amount. In this case, the ureteral catheters 112, 114 pass through the uncovered portion of the cage 210.
The cage 210 and cover 214 may be collapsed together from a collapsed position in which the members 212 are tightly collapsed together about the central portion and/or about the bladder catheter 116 to allow insertion through the catheter or sheath to an expanded position. For example, in the case of a cage 210 formed of a shape memory material, the cage 210 may be configured to transition to the deployed position when heated to a sufficient temperature, such as body temperature (e.g., 37 ℃). In the deployed position, the cage 210 has a diameter D that is preferably wider than the urethral orifice, such that the cage 210 provides support for the ureteral catheter 112, 114 and prevents patient movement through the ureteral catheter 112, 114 to the ureter. When the assembly 200 is deployed in the urinary tract, the ureteral catheters 112, 114 extend from the open distal end 248 of the bladder catheter 216, over the longitudinally extending members 212 of the cage 210, and into the bladder. Advantageously, the open (e.g., lower view) arrangement of members 212 or tines facilitates manipulation of ureteral catheters 112, 114 from and through bladder catheter 116. In particular, the open arrangement of members 212 or tines does not block or obstruct the distal port 248 and/or the fluid-conducting port 216 of the bladder catheter, making manipulation of the catheters 112, 114 easier.
Referring to fig. 16, portions of another example of a urine collection assembly 100b are illustrated. The urine collection assembly 100b includes a first ureteral catheter 112b and a second ureteral catheter 114b. The assembly 100b does not contain a separate bladder fluid guide catheter as provided by the previous example. Conversely, one ureteral catheter 112b includes a coiled portion 127b formed by a middle portion of the catheter 112b (e.g., the portion of the catheter configured to be positioned below the patient's bladder). The spiral portion 127b comprises at least one and preferably two or more coils 176b. Coil 176b may be constructed by bending conduit 138b to provide the desired coil shape. The lower coil 178b of the helical portion 127b is configured to rest against and/or seat adjacent the urethral orifice. Desirably, the coiled portion 127b has a diameter D that is greater than the urethral orifice to prevent the coiled portion 127b from sucking into the urethra. In some examples, a port 142b or opening is placed in a sidewall of the catheter 138b for connecting the first ureteral catheter 112b with the second ureteral catheter 114b. For example, the second catheter 114b may be inserted into the port 142b to form a fluid connection between the first ureteral catheter 112b and the second ureteral catheter 114b. In some examples, second conduit 114b terminates at a location just inside of catheter lumen 140b of first conduit 112 b. In other examples, the second ureteral catheter 114b extends through and/or with the length of the mansion 140b of the first catheter 112b, but is not in fluid communication with the mansion 140 b.
Referring again to fig. 11A and 11B, another exemplary urine collection assembly 100 including a bladder fluke device 134 is illustrated. The assembly 100 includes ureteral catheters 112, 114 and a separate bladder catheter 116. More specifically, as in the previous examples, the assembly 100 includes ureteral catheters 112, 114, each of which includes a distal portion 118 located in or near the right and left kidneys, respectively. Ureteral catheters 112, 114 contain indwelling portions 118, 126, 128 that extend through the ureter, bladder and urethra. Ureteral catheters 112, 114 further include an outer portion 170 that extends from the patient's urethra 12 to the pump assembly for delivering negative pressure to the renal pelvis and/or kidneys. The assembly 100 also includes a bladder fluke device 134 that includes a bladder catheter 116 and a fluke 136 (e.g., a Foley catheter) that deploys within the bladder to prevent or reduce the effect of patient activity being transferred to the ureteral catheters 112, 114 and/or ureters. Bladder conduit 116 extends from bladder 10 through the urethra to a fluid collection vessel for fluid collection by gravity or negative pressure drainage. In some examples, the outer portion of the tube (shown in fig. 19) extending between the collection container 712 and the pump 710 may contain one or more filters that prevent urine and/or particulates from entering the pump. As in the previous examples, a bladder catheter 116 is provided that drains excess urine left in the patient's bladder during catheter placement.
Exemplary connectors and clamps:
referring to fig. 1, 11A and 17A-17C, the assembly 100 further includes a manifold or connector 150 for connecting two or more of the conduits 112, 114, 116 at a location outside the patient's body. In some examples, the connector 150 may be a clamp, manifold, valve, fastener, or other element provided with a fluid path for connecting the catheter with an external flexible tube as known in the art. As shown in fig. 17A and 17B, the manifold or connector 150 comprises a two-piece body having an interior portion 151 housed within a housing 153. The inner portion 151 defines a channel for guiding fluid between the inflow ports 154, 155 and the outflow port 158. The inflow ports 154, 155 may include a threaded receptacle 157 configured to receive a proximal portion of the conduits 112, 114. Suitably, the receptacle 157 is of a size suitable to securely receive and retain flexible tubing of a size between 1Fr and 9 Fr. Generally, the user rotates the socket 157 into the ports 154, 155 in the direction of arrow A1, tightening the socket 157 around each conduit 122 (7B shown in FIG. 1).
Once the conduits 112, 114 are loaded into the connector 150, urine entering the connector 150 through the vacuum flow inlets 154, 155 is directed to the vacuum flow outlet 158 via the fluid conduit (shown in fig. 17B) in the direction of arrow A2. The vacuum flow outlet 158 may be connected to the fluid collection container 712 and/or pump assembly 710 (shown in fig. 19) by, for example, a flexible tube 166 defining a fluid flow path.
With specific reference to fig. 17C, another exemplary connector 150 may be configured to connect 3 or more conduits 112, 114, 116 with outflow ports 158, 162. The connector 150 may include a structure or body having a distal side 152, the distal side 152 including two or more vacuum inflow ports 154, 155 configured to connect with the proximal ends of the ureteral catheters 112, 114 and a separate gravity drainage port 156 configured to connect with the proximal end of the bladder catheter 116. The vacuum ports 154, 155 and/or the proximal ends of the ureteral catheters 112, 114 may include specific structures to ensure that the ureteral catheters 112, 114 are connected to a vacuum source and not to some other fluid collection assembly. Similarly, the gravity drainage port 156 and/or the proximal end of the bladder catheter 116 may include another connector structure to ensure that the bladder catheter 116, and not one of the ureteral catheters 112, 114, is permitted to drain by gravity. In other examples, the ports 154, 155, 156 and/or the proximal ends of the catheters 112, 114, 116 may include visual indicia to aid in properly positioning the fluid collection system.
In some examples, urine received in the vacuum ports 154, 155 may be directed through a Y-shaped conduit to a single vacuum outflow port 158 located at the proximal side 160 of the connector 150. As in the previous examples, vacuum outflow port 158 may be connected to fluid collection container 712 and/or pump 710 by a suitable flexible tube or other conduit for aspirating urine from the body and for introducing negative pressure into the ureters and/or kidneys. In some examples, the outflow port 156 and/or the connector 150 may be configured to connect only with a vacuum source or pump operating within a predetermined pressure range or power level to prevent exposure of the ureteral catheter 112, 114 to elevated negative pressure levels or intensities. The proximal side 160 of the connector 150 may also include a gravitational flow outlet 162 in fluid communication with the flow inlet 156. The gravity flow outlet 162 may be configured to connect directly with the urine collection container 712 for urine collection by gravity drainage.
With continued reference to fig. 17C, in some examples, to facilitate system setup and execution, the vacuum flow outlet 158 and the gravity flow outlet 162 are placed in close proximity such that a single socket 164, bracket, or connector may be coupled with the connector 150 in fluid communication with each port 158, 162. The single socket or connector may be coupled with a multi-conduit hose or tube (e.g., flexible tube 166) having a first conduit in fluid communication with the pump 710 and a second conduit in fluid communication with the collection container 712. Thus, a user can easily set up an external fluid collection system (shown in FIG. 19) by inserting the single receptacle 164 into the connector 150 and connecting the corresponding tubing to one of the fluid collection container 712 and the pump 710. In other examples, one section of flexible tubing 166 is connected between urine collection container 712 and gravitational flow port 162, and a different section of flexible tubing is connected between pump 710 and vacuum flow port 158.
Exemplary fluid sensor:
referring again to fig. 1, in some examples, the assembly 100 further includes a sensor 174 for monitoring a fluid property of urine collected from the ureters 6, 8 and/or bladder 10. As described herein in connection with fig. 19, information obtained from the sensor 174 may be sent to a central data collection module or processor and used, for example, to control the operation of an external device such as a pump 710 (shown in fig. 19). The sensor 174 may be integrally formed with one or more of the catheters 112, 114, 116, such as embedded in the wall of the catheter body or tube and in fluid communication with the catheter lumens 124, 140. In other examples, one or more of the sensors 174 may be placed in the fluid collection vessel 712 (shown in fig. 19) or in an internal circuit of an external device (e.g., pump 710).
Exemplary sensors 174 that may be used with the urine collection assembly 100 may include one or more of the following sensor types. For example, catheter assembly 100 may include conductivity sensors or electrodes that sample the conductivity of the urine. The normal conductivity of human urine is about 5-10mS/m. Urine with conductivity outside the expected range may indicate that the patient is experiencing physiological problems that require further treatment or analysis. The catheter assembly 100 may also include a flow meter for measuring the flow rate of urine through the catheters 112, 114, 116. The flow rate can be used to determine the total volume of fluid excreted in the body. The conduits 112, 114, 116 may also include a thermometer for measuring the temperature of the urine. Urine temperature can also be used in conjunction with conductivity sensors. Urine temperature can also be used for monitoring purposes, as urine temperatures outside of the normal range of physiology can be indicative of certain physiological conditions.
A method of inserting a urine collection assembly:
having described a urine collection assembly 100 including a ureteral catheter retention portion and a bladder fluke device (e.g., a standard or modified Foley type catheter), the method for insertion and deployment of the assembly will now be described in detail.
With reference to fig. 18A, steps for placing a fluid collection assembly on a patient's body and optionally introducing negative pressure into the ureters and/or kidneys of the patient are illustrated. As shown in block 610, a medical professional or caregiver inserts and inserts a flexible or rigid cystoscope through the patient's urethra and into the bladder to obtain a visualization of the ureteral orifice or mouth. Once the appropriate contrast is obtained, as shown in block 612, the lead is advanced through the urethra, bladder, ureteral orifice, ureter, and into the desired fluid collection site, e.g., renal pelvis of the kidney. Once the guide wire is advanced to the desired fluid collection location, the ureteral catheter of the present invention (examples of which are described in detail above) is inserted over the guide wire into the fluid collection location, as shown in block 614. In some examples, the position of the ureteral catheter may be confirmed by fluoroscopy, as shown in block 616. Once the position of the distal end of the catheter is verified, as shown in block 618, the retention portion of the ureteral catheter may be deployed. For example, the guide wire may be removed from the catheter, thus allowing the distal end and/or the retention portion to transition to the deployed position. In some instances, the deployed distal portion of the catheter does not completely occlude the ureter and/or renal pelvis, allowing urine to pass from outside the catheter, through the ureter, and into the bladder. Since the moving catheter can exert forces on the urinary tract tissue, avoiding complete blockage of the ureter avoids exerting forces on the ureter sidewall, which can cause damage.
After the ureteral catheter is in place and deployed, a second ureteral catheter may be placed in another ureter and/or kidney using the same guide wire, using the same insertion and placement methods described herein. For example, cystoscopy may be used to obtain an image of another ureteral orifice in the bladder, and a guide wire may be advanced through the visible ureteral orifice to a fluid collection site in the other ureter. The catheter may be withdrawn along the guidewire and deployed in the manner described above. Alternatively, the cystoscope and lead may be removed from the body. The cystoscope may be reinserted into the bladder over the first ureteral catheter. Cystoscopes are used in the manner described above to obtain a visualization of the ureteral orifice and to facilitate advancement of the second guide wire to the second ureter and/or kidney for placement of the second ureteral catheter. In some examples, once the ureteral catheter is in place, the guide wire and cystoscope are removed. In other examples, cystoscopes and/or leads may remain in the bladder to aid in placement of the bladder catheter.
Optionally, a bladder catheter may also be used. Once the ureteral catheter is in place, as shown in block 620, a medical professional or caregiver may insert the distal end of the bladder catheter through the patient's urethra and into the bladder in a collapsed or contracted state. The bladder catheter may be a conventional Foley bladder catheter or a bladder catheter of the invention as described in detail above. Once inserted into the bladder, as shown in block 622, the anchor hooks attached and/or coupled to the bladder catheter are opened to a deployed position. For example, when using an expandable or inflatable catheter, fluid may be introduced through the inflation lumen of the bladder catheter to expand a balloon structure located in the patient's bladder. In some examples, the bladder catheter is inserted through the urethra and into the bladder without the use of a guide wire and/or cystoscope. In other examples, the bladder catheter is inserted over the same guide wire that is used to place the ureteral catheter. Thus, when inserted in this manner, the ureteral catheter may be arranged to extend from the distal end of the bladder catheter, optionally, the proximal end of the ureteral catheter may be arranged to terminate in the drainage lumen of the bladder catheter.
In some examples, urine is allowed to drain from the urethra by gravity. In other examples, negative pressure is introduced into the ureteral catheter and/or the bladder catheter to facilitate drainage of urine.
Referring to fig. 18B, a step of using a urine collection assembly for introducing negative pressure into the ureter and/or kidney is illustrated. After proper placement of the indwelling portion of the bladder and/or ureteral catheter and deployment of the anchoring/retention structure, the external proximal end of the catheter is connected to a fluid collection or pump assembly, as shown in block 624. For example, a ureteral catheter may be connected to a pump for introducing negative pressure in the renal pelvis and/or kidneys of a patient. In a similar manner, the bladder catheter may be directly connected to a urine collection container for gravity drainage of urine from the bladder or to a pump for introducing negative pressure in the bladder.
Once the catheter and pump assembly are connected, negative pressure is applied to the renal pelvis and/or kidney and/or bladder through the drainage lumen of the ureteral catheter and/or bladder catheter, as shown in block 626. Negative pressure is intended to combat hyperemia-mediated interstitial hydrostatic pressure due to elevated intra-abdominal pressure and indirectly or elevated renal venous or lymphatic pressure. The applied negative pressure can thus increase the flow of exudates through the medullary canaliculus and can reduce water and sodium reabsorption.
In some examples, mechanical stimulation may be provided to the ureter and/or a portion of the renal pelvis to supplement or correct the therapeutic effect obtained by the application of negative pressure. For example, a mechanical stimulation device, such as a linear actuator, and other known devices that provide, for example, vibration waves, may be activated at the distal portion of the ureteral catheter. Without being bound by theory, it is believed that such stimulation affects adjacent tissue by, for example, stimulating nerves and/or initiating peristaltic muscles associated with the ureter and/or renal pelvis. Stimulation of nerves and activation of muscles can create pressure gradients or changes in pressure levels in surrounding tissues and organs, which can help or in some cases enhance the therapeutic benefits of negative pressure therapy. In some examples, the mechanical stimulus may include a pulsed stimulus. In other examples, low levels of mechanical stimulation may be continuously provided as negative pressure provided through the ureteral catheter. In other examples, the inflatable portion of the ureteral catheter may be inflated and collapsed in a pulsed manner to stimulate adjacent nerve and muscle tissue in a similar manner to that of the mechanical stimulation devices described herein.
As a result of the applied negative pressure, urine is drawn into the catheter at its distal plurality of fluid conduction ports, through the catheter's fluid conduction lumen, and into the fluid collection container for disposal, as shown in block 628. As urine is drawn into the collection container in block 630, sensors placed in the fluid collection system provide information about a plurality of measurements of the urine (which can be used to evaluate the volume of urine collected) as well as about the patient's physical condition and the composition of the urine produced. In some examples, as shown in block 632, the information obtained by the sensor is processed by a processor associated with the pump and/or another patient monitoring device at block 634 and displayed to the user by a visual display device of the associated feedback device.
Exemplary fluid collection system:
having described exemplary urine collection assemblies and methods of placing such assemblies in a patient's body, a system 700 for introducing negative pressure into the ureters and/or kidneys of a patient will now be described with reference to fig. 19. The system 700 may include the ureteral catheter, bladder catheter, or urine collection assembly 100 described above. As shown in fig. 19, ureteral catheters 112, 114 and/or bladder catheter 116 of assembly 100 are connected to one or more fluid collection containers 712 for collecting urine withdrawn from the renal pelvis and/or bladder. In some examples, the bladder catheter 116 and ureteral catheters 112, 114 are connected to different fluid collection containers 712. A fluid collection reservoir 712 connected to the ureteral catheters 112, 114 may be in fluid communication with an external fluid pump 710 for creating negative pressure in the ureters and kidneys through the ureteral catheters 112, 114. As described herein, the negative pressure may be provided to overcome interstitial pressure and form urine in the kidneys or nephrons. In some examples, the connection between the fluid collection container 712 and the pump 710 may include a fluid lock or fluid barrier to prevent gas from entering the renal pelvis or kidney in the event of sporadic therapeutic or non-therapeutic pressure changes. For example, the inflow and outflow of the fluid container may be placed below the fluid level in the container. Thus, gas is prevented from entering the medical tube or catheter through the inflow and outflow openings of the fluid container 712. As previously described, the outer portion extending between the fluid collection container 712 and the pump 710 may include one or more filters to prevent urine and/or particulates from entering the pump 710.
As shown in fig. 19, the system 700 further comprises a controller 714, such as a microprocessor, electronically coupled to the pump 710 and having a computer readable memory 716 or associated therewith. In some examples, the memory 716 includes instructions that when executed cause the controller 714 to receive information from the sensor 174 located in or associated with a portion of the assembly 100. Information about the patient's condition may be determined based on information from the sensors 174. Information from the sensor 174 may also be used to determine and execute operating parameters of the pump 710.
In some examples, the controller 714 is integrated into a separate remote electronics, such as a dedicated electronics, computer, tablet PC, or smart phone, that communicates with the pump 710. Alternatively, the controller 714 may be included in the pump 710 and, for example, a user interface may be controlled to manually operate the pump 710 as well as system functions such as receiving and processing information from the sensor 174.
The controller 714 is configured to receive information from the one or more sensors 174 and store the information in an associated computer-readable memory 716. For example, the controller 714 may be configured to receive information from the sensor 174 at a predetermined rate (e.g., once per second) and determine the conductivity based on the received information. In some examples, the algorithm for calculating conductivity also includes other sensor measurements, such as urine temperature, to obtain a more complete determination of conductivity.
The controller 714 may also be configured to calculate patient body statistics or diagnostic indicators that account for patient condition over time. For example, the system 700 may be configured to identify the total amount of sodium expelled. The total sodium displaced may be based on, for example, a combination of flow rate and conductivity over a period of time.
With continued reference to fig. 19, the system 700 may further include feedback means 720, such as a visual display device or an audio system, to provide information to the user. In some examples, feedback device 720 may be integrally formed with pump 710. Alternatively, feedback device 720 may be a separate dedicated or multi-purpose electronic device, such as a computer, portable computer, tablet PC, smart phone, or other handheld electronic device. The feedback device 720 is configured to receive the calculated or ascertained measurements from the controller 714 and provide information to the user via the feedback device 720. For example, feedback device 720 may be configured to display the current negative pressure (in mmHg) being applied to the urinary tract. In other examples, the feedback device 720 is configured to display the current urine flow rate, temperature, current conductivity of urine (in mS/m), total urine volume produced during the measurement period, total sodium excreted during the measurement period, other body parameters, or any combination thereof.
In some examples, feedback device 720 further includes a user interface module or component that allows a user to control the operation of pump 710. For example, a user may engage or turn off the pump 710 via a user interface. The user may also adjust the pressure applied by the pump 710 to achieve a greater value or rate of sodium excretion and fluid drainage.
Optionally, the feedback device 720 and/or the pump 710 further comprises a data transmitter 722 for transmitting information from the device 720 and/or the pump 710 to other electronics or a computer network. The data transmitter 722 may utilize a short range or long range data communication protocol. An example of a short range data transfer protocol isThe remote data transmission network includes, for example, wi-Fi or cellular networks. The data transmitter 722 may transmit information to the patient's doctor or caregiver informing the doctor or caregiver about the patient's existing condition. Alternatively or in addition, information may be sent from the data transmitter 722 to an existing database or information storage unit, for example, to incorporate recorded information into a patient's Electronic Health Record (EHR).
Referring to fig. 20A and 20B, an exemplary pump 710 for use with the system is illustrated. In some examples, pump 710 is a micropump configured to aspirate fluid from catheters 112, 114 (e.g., shown in fig. 1) and having a sensitivity or accuracy of about 10mmHg or less. Suitably, the pump 710 is capable of providing a urine flow rate range between 0.05ml/min and 3ml/min for a long period of time, such as from about 8 hours to about 24 hours per day for one (1) to about 30 days or more. At 0.2mL/min, system 700 expects to collect about 300mL of urine per day. The pump 710 may be configured to provide negative pressure to the patient's bladder, ranging from about 0.1mmHg and 50mmHg or from about 5mmHg to about 20mmHg (gauge pressure on the pump 710). For example, micropumps (model BT 100-2J) manufactured by Langer inc. Can be used with the system 700 disclosed herein. Diaphragm pumps, as well as other types of commercially available pumps, may also be used for this purpose. Peristaltic pumps may also be used with the system 700. In other examples, a piston pump, vacuum bottle, or manual vacuum source may be used to provide negative pressure. In other examples, the system may be connected to a wall suction source (wall suction source) such as is available in a hospital through a vacuum regulator for reducing negative pressure to a therapeutically appropriate level.
In some examples, the pump 710 is configured for extended use, and thus is capable of maintaining accurate suction for a long period of time, such as from about 8 hours to about 24 hours per day for 1 to about 30 days or more. Further, in some examples, the pump 710 is configured to be manually operated, and in this case, includes a control panel 718 that allows the user to set the desired suction value. The pump 710 also includes a controller or processor, which may be the same controller that operates the system 700 or may be a separate processor dedicated to operating the pump 710. In either case, the processor is configured to both accept instructions for manually operating the pump and to automatically operate the pump 710 in accordance with predetermined operating parameters. Alternatively or in addition, the operation of the pump 710 may be controlled by a processor based on feedback received from a plurality of sensors coupled to the catheter.
In some examples, the processor is configured to cause the pump 710 to operate intermittently. For example, the pump 710 may be configured to emit a negative pressure pulse followed by a period in which no negative pressure is provided. In other examples, pump 710 may be configured to alternate between providing negative and positive pressure to create alternating flushing and pumping effects. For example, a positive pressure of about 0.1mmHg to 20mmHg, preferably about 5mmHg to 20mmHg, followed by a negative pressure in the range of about 0.1mmHg to 50mmHg, may be provided.
Experimental examples:
negative pressure introduction was performed within the pig's renal pelvis in the feedlot to evaluate the effect of negative pressure therapy on renal congestion in the kidneys. The purpose of these studies was to demonstrate whether the negative pressure delivered into the renal pelvis significantly increased urine drainage in a renal hyperemic pig model. In example 1, a pediatric Fogarty catheter, which is commonly used for embolic clearance or bronchoscopy applications, was used in a pig model, merely to demonstrate the principle of introducing negative pressure into the renal pelvis. The use of Fogarty catheters in a human clinical setting to avoid damage to urinary tract tissue has not been proposed. In example 2, ureteral catheter 112 shown in fig. 2A and 2B and including a helical retention portion that mounts or holds the distal portion of the catheter in the renal pelvis or kidney was used.
Example 1
Method
A 4-head feedlot pig 800 was used to evaluate the effect of negative pressure therapy on renal congestion in the kidneys. As shown in fig. 21, pediatric Fogarty catheters 812, 814 are inserted into the renal pelvis regions 820, 821 of each kidney 802, 804 of a 4-head pig 800. The catheters 812, 814 are deployed within the renal pelvis region by inflating the expandable balloon to a size sufficient to occlude the renal pelvis and maintain the position of the balloon within the renal pelvis. Catheters 812, 814 extend from the renal pelvis 802, 804, through the bladder 810 and urethra 816, and into a fluid collection reservoir external to the pig.
Urine discharge from 2 animals was collected for a period of 15 minutes to establish a baseline for urine output and rate. The urine output of the right kidney 802 and left kidney 804, respectively, was measured and found to vary greatly. Creatinine clearance values were also determined.
Partial occlusion of the Inferior Vena Cava (IVC) with the inflatable balloon catheter 850 just above the outflow port of the renal veins induces renal congestion (e.g., congestion or reduced blood flow in the renal veins) in the right kidney 802 and left kidney 804 of the animal 800. IVC pressure was measured using a pressure sensor. Normal IVC pressures are 1-4mmHg. The IVC pressure is raised to between 15-25mmHg by inflating the balloon of catheter 850 to about three-quarters of the IVC diameter. Inflation of the balloon to approximately three-quarters of the IVC diameter resulted in a 50-85% reduction in urine output. Complete occlusion produces an IVC pressure above 28mmHg and is associated with at least a 95% reduction in urine output.
One kidney of each animal 800 was untreated and served as a control ("control kidney 802"). Ureteral catheter 812, extending from the control kidney, was connected to fluid collection container 819 for the determination of fluid level. One kidney of each animal ("treating kidney 804") is treated with negative pressure from a source of negative pressure (e.g., treatment pump 818 along with a low magnitude regulator designed to more accurately control the negative pressure) connected to ureteral catheter 814. Pump 818 is from Air Cadet Vacuum Pump (model EW-07530-85) of Cole-Parmer Instrument Company. The pump 818 is connected in series with the regulator. The regulator is a V-800Series Miniature Precision Vacuum Regulator-1/8NPT Ports (model V-800-10-W/K) manufactured by Airtrol Components Inc.
The pump 818 is activated to introduce negative pressure into the renal pelvis 820, 821 of the treating kidney, as follows. First, the effect of negative pressure in normal conditions (e.g., without inflating an IVC balloon) was studied. 4 different pressure levels (-2, -10, -15, and-20 mmHg) were applied for 15 minutes each and the rate of urine produced and creatinine clearance were determined. The pressure level is controlled and measured on the regulator. After-20 mmHg treatment, the IVC balloon was inflated to increase the pressure by 15-20mmHg. The same 4 negative pressure levels were applied. Control kidney 802 with congestion and treated kidney 804 were obtained for urinary flow rate and creatinine clearance. Animal 800 was subjected to congestion by partially blocking IVC for 90 minutes. For a 90 minute hyperemia period, 60 minutes of treatment is provided.
After collection of urine drainage and creatinine clearance data, kidneys of one animal were visually inspected and then fixed in 10% neutral buffered formalin. After visual inspection, tissue sections are obtained, inspected, and magnified images of the sections are taken. Sections were examined using a vertical Olympus BX41 optical microscope and images were taken using an Olympus DP25 digital camera. In particular, photomicrographic images of the sampled tissue were obtained at low magnification (20 x original magnification) and high magnification (100 x original magnification). Histological evaluation was performed on the obtained image. The purpose of the evaluation is to histologically examine the tissue and to qualitatively characterize the hyperemia and tubule degeneration of the obtained samples.
Surface mapping analysis was also performed on the obtained kidney tissue slides. Specifically, the samples were stained and analyzed to evaluate differences in tubular size between treated and untreated kidneys. Image processing techniques calculate the numerical value and/or relative percentages of pixels in a stained image that have different stains. The volume of the different anatomical structures is determined using the calculated measurement data.
Results
Urine output and creatinine clearance
The urine flow rate is highly variable. 3 causes of changes in urine flow rate were observed during the study. Inter-individual and hemodynamic variability is the expected cause of variability known in the art. The identification of the 3 rd cause of the change in urine output in the experiments described herein, i.e. the in vivo variability in contralateral individuals of urine output, is considered as previously unknown information and concept.
One kidney has a baseline urine flow rate of 0.79ml/min and the other kidney has a baseline urine flow rate of 1.07ml/min (e.g., 26% difference). The urine flow rate is the average rate calculated from the urine flow rate of each animal.
When congestion is provided by inflating the IVC balloon, the therapeutic renal urine output drops from 0.79ml/min to 0.12ml/min (15.2% of baseline). In contrast, control renal urinary flow rate decreased from 1.07ml/min to 0.09ml/min (8.4% of baseline) during hyperemia. The relative increase in the treated renal urine output compared to the control renal urine output was calculated according to the following equation based on the urine flow rate:
(therapeutic/baseline therapeutic)/(therapeutic control/baseline control) =relative increase
(0.12ml/min/0.79ml/min)/(0.09ml/min/1.07ml/min)
＝180.6％
Thus, the relative increase in therapeutic renal urinary flow rate compared to the control was 180.6%. This result shows a greater reduction in urine production caused by congestion in the control side when compared to the treatment side. The result was a relative percentage difference adjustment of urine output of the difference in urine output between kidneys.
The measurement of creatinine clearance for baseline, hyperemia and treatment fractions of one of the animals is shown in figure 22.
Visual inspection and histological evaluation
From visual inspection of the control kidney (right kidney) and the treated kidney (left kidney), it was determined that the control kidney had a consistent dark reddish brown, which corresponds to more congestion in the control kidney than the treated kidney. Qualitative evaluation of the magnified cross-sectional images also noted increased congestion in the control kidney compared to the treated kidney. In particular, as shown in table 1, the treated kidneys showed lower levels of hyperemia and tubule degeneration compared to the control kidneys. The following qualitative scale was used to evaluate the resulting slides.
Congestion of blood
Tubular denaturation
Element 1
List results
As shown in table 1, the treated kidneys (left kidneys) showed only slight hyperemia and tubular degeneration. In contrast, the control kidney (right kidney) showed moderate hyperemia and tubule degeneration. These results were obtained by analyzing the following slides.
Fig. 23A and 23B are low and high magnification micrographs of the left kidney of an animal (treated with negative pressure). From histological review, slight hyperemia of the blood vessels at the pithelial junction was identified, as indicated by the arrow. As shown in fig. 23B, individual tubules having transparent tubular shapes (identified by asterisks) were identified.
Fig. 23C and 23D are low and high resolution micrographs of control kidneys (right kidneys). Based on histological review, moderate congestion of blood vessels at the pithelial junction was identified, as indicated by the arrow in fig. 23C. As shown in fig. 23D, several tubules with transparent tubular shapes appear to be present in the tissue sample (identified by asterisks in the image). The presence of a considerable amount of transparent tubing is evidence of hypoxia.
Surface mapping analysis provides the following results. The therapeutic kidneys were measured to have 1.5 times the fluid volume in the renal small lumen and 2 times the fluid volume in the small lumen. An increase in fluid volume in the renal small lumen and small lumen corresponds to an increase in urine output. In addition, the treated kidneys were determined to have 1/5 of the blood volume in capillaries as compared to the control kidneys. The increase in therapeutic kidney volume appears to be the result of: (1) Each capillary is reduced in size compared to a control, and (2) the number of capillaries in the treated kidney is increased without visible red blood cells compared to a control kidney, an indicator of less congestion in the treated organ.
Summary of the inventionsummary
These results indicate that the control kidney has more congestion and more tubules with intraluminal transparent ducts than the treated kidney, which represents protein-rich intraluminal material. Thus, treating kidneys showed a lower degree of loss of kidney function. Without being bound by theory, it is believed that severe hyperemia occurs in the kidneys followed by hypoxia of the organs. Hypoxemia interferes with oxidative phosphorylation (e.g., ATP production) within organs. Loss of ATP and/or reduced ATP production inhibits active transport of the protein, resulting in increased intraluminal protein content, which appears as a transparent tube. The number of tubular ducts with intraluminal transparent ducts is related to the degree of loss of kidney function. Thus, the treatment of a decrease in the number of tubules in the left kidney is considered physiologically important. Without being bound by theory, it is believed that these results indicate that damage to the kidneys may be prevented or inhibited by introducing negative pressure into the catheter inserted into the renal pelvis to facilitate urine drainage.
Examples2
Method
Four (4) farm pigs (a, B, C, D) were sedated and anesthetized. Vital signs of each pig were monitored throughout the experiment, and cardiac output was measured at the end of each 30 minute period of the study. Ureteral catheters, such as ureteral catheter 112 shown in fig. 2A and 2B, were deployed in the renal pelvis region of the kidneys of each pig. The deployment catheter is a 6Fr catheter with an outer diameter of 2.0±0.1mm. The length of the catheter was 54.+ -.2 cm, excluding the distal retention section. The length of the retention portion was 16±2mm. As shown in the catheter 112 of fig. 2A and 2B, the retention portion includes two complete coils and one proximal half coil. The outside diameter of the completed coil, shown by line D1 in FIGS. 2A and 2B, is 18.+ -.2 mm. The half coil diameter D2 is 14mm. The retention portion of the deployed ureteral catheter includes 6 fluid-conducting holes, plus an additional hole at the distal end of the catheter. The diameter of each liquid guide hole is 0.83+/-0.01 mm. The distance between adjacent weep holes 132, precisely the linear distance between weep holes when the coil is straightened, is 22.5 + -2.5 mm.
Ureteral catheters were placed to extend from the pig renal pelvis through the bladder and urethra to a fluid collection reservoir external to each pig. After placement of the ureteral catheter, a pressure sensor for measuring IVC pressure is placed in the IVC at a location distal to the renal vein. An inflatable balloon catheter, precisely manufactured by NuMED inc (Hopkinton, NY)A percutaneous balloon catheter (30 mm diameter X5cm length) extends in the IVC at a location proximal to the renal vein. The thermal dilution catheter, precisely Swan-Ganz thermal dilution pulmonary artery catheter manufactured by edwards. Life sciences corp. (Irvine, CA), was then placed in the pulmonary artery for the purpose of measuring cardiac output.
First, baseline urine output was measured for 30 minutes, and blood and urine samples were collected for biochemical analysis. After a 30 minute baseline period, the balloon catheter was inflated to increase the IVC pressure from a baseline pressure of 1-4mmHg to a high hyperemic pressure of about 20mmHg (+/-5 mmHg). The hyperemic baseline was then collected for 30 minutes, accompanied by corresponding blood and urine analysis.
At the end of the hyperemic period, high hyperemic IVC pressure was maintained and negative pressure diuretic therapy was provided to pigs a and C. In particular, pigs (a, C) were treated by applying negative pressure of-25 mmHg via ureteral catheter with a pump. As in the previous example, the pump was Air Cadet Vacuum Pump (model EW-07530-85) from Cole-Parmer Instrument Company. The pump is connected in series with the regulator. The regulator is a V-800Series Miniature Precision Vacuum Regulator-1/8NPT Ports (model V-800-10-W/K) manufactured by Airtrol Components Inc. Pigs were observed for 120 minutes at the time of treatment. Blood and urine collection was performed every 30 minutes during the treatment period. Two pigs (B, D) served as hyperemic controls (e.g Does not takeApplying negative pressure to the renal pelvis through ureteral catheter) treatmentThis means that 2 pigs (B, D) did not receive negative pressure diuretic therapy.
After collecting urine output and creatinine clearance data for the 120 minute treatment period, animals were sacrificed and kidneys from each animal were visually inspected. After visual inspection, tissue sections are obtained and inspected, and magnified images of the sections are taken.
Results
Table 2 provides measurements collected at baseline, hyperemia, and treatment periods. Specifically, urine output, serum creatinine, and urine creatinine measurements were obtained at each time. These values allow the measured creatinine clearance to be calculated as follows:
creatinine clearance rate: crCl
Urine output (ml/min) ×urine creatinine (mg/dl)/serum creatinine (mg/dl)
In addition, neutrophil gelatinase-associated lipocalin (NGAL) values were measured for serum samples obtained from each period, and kidney injury molecule 1 (KIM-1) values were measured for urine samples obtained from each period. Table 2 also includes qualitative histological examination results determined in the resulting tissue section examinations.
TABLE 2
Data as original (% baseline)
* Not measured
* Confusion by phenylephrine
Animal a: animals weighed 50.6kg, baseline urine flow rate 3.01ml/min, baseline serum creatinine 0.8mg/dl, and calculated CrCl 261ml/min. Note that these measurements were atypically high relative to other animals studied, except serum creatinine. Congestion was associated with a 98% decrease in urine flow rate (0.06 ml/min) and a >99% decrease in CrCl (1.0 ml/min). Treatment with negative pressure applied through ureteral catheters was associated with urine output and CrCl of 17% and 12% of baseline values and 9x and >10x of hyperemia values, respectively. The levels of NGAL varied throughout the experiment, ranging from 68% of baseline during congestion to 258% of baseline after 90 minutes of treatment. The final value was 130% of baseline. The level of KIM-1 was 6-fold and 4-fold of baseline for the first two 30-minute windows after baseline evaluation before increasing to 68x, 52x and 63x, respectively, of baseline values for the last 3 collection periods. Serum creatinine was 1.3mg/dl for 2 hours. Histological examination showed an overall congestion level of 2.4% as measured by blood volume in the capillary lumen. Histological examination also noted tubules with intraluminal transparent tubes, some degree of tubular epithelial degeneration, examination results consistent with cellular damage.
Animal B: animals weighed 50.2kg, baseline urine flow rate 2.62ml/min, and estimated CrCl 172ml/min (also higher than expected). Congestion was associated with an 80% decrease in urine flow rate (0.5 ml/min) and an 83% decrease in CrCl (30 ml/min). After 50 minutes into hyperemia (20 minutes after the baseline period of hyperemia), the animals experience a sudden drop in mean arterial pressure and respiration rate, followed by tachycardia. The anesthesiologist administers a dose of phenylephrine (75 mg) to prevent cardiogenic shock. Intravenous administration of phenylephrine is prescribed when blood pressure falls below safe levels during anesthesia. However, because the experiment is testing the effect of congestion on renal physiology, phenylephrine is administered to confound the remainder of the experiment.
Animal C: animals weighed 39.8kg, a baseline urine flow rate of 0.47ml/min, a baseline serum creatinine of 3.2mg/dl, and a measured CrCl of 5.4ml/min. Congestion was associated with a 75% decrease in urine output (0.12 ml/min) and a 79% decrease in CrCl (1.6 ml/min). The baseline NGAL level was determined to be >5x upper normal limit (ULN). Treatment with negative pressure applied to the renal pelvis via ureteral catheters was associated with normalization of urine output (101% of baseline) and 341% improvement in CrCl (18.2 ml/min). The levels of NGAL varied throughout the experiment, ranging from 84% to 47% -84% of baseline between 30 and 90 minutes during baseline hyperemia. The final value was 115% of baseline. The level of KIM-1 decreased 40% from baseline during the first 30 minutes of congestion, followed by the remaining 30 minute window at 8.7x, 6.7x, 6.6x and 8x, respectively, which increased to baseline values. Serum creatinine levels at 2 hours were 3.1mg/dl. Histological examination showed a global hyperemia level of 0.9%, measured by blood volume in the capillary lumen. Note that the tubules are histologically normal.
Animal D: animals weighed 38.2kg, baseline urine output 0.98ml/min, baseline serum creatinine 1.0mg/dl, and measured CrCl 46.8ml/min. Congestion was associated with a 75% decrease in urine flow rate (0.24 ml/min) and a 65% decrease in Cr Cl (16.2 ml/min). Continuous hyperemia was associated with a 66% -91% decrease in urine output and a 89% -71% decrease in CrCl. The levels of NGAL varied throughout the experiment, ranging from 127% of baseline to 209% of baseline final value during hyperemia. Levels of KIM-1 remained between 1x and 2x of baseline for the first two 30 min windows after baseline evaluation, followed by 190x, 219x and 201x increases to baseline values for the last 3 30 min periods. Serum creatinine levels were 1.7mg/dl for 2 hours. Histological examination showed an overall congestion level of 2.44x observed in the tissue samples of the treated animals (a, C), with an average capillary size of 2.33 times that observed in either of the treated animals. Histological evaluation also noted several tubules with intraluminal transparent ducts and a degeneration of the epithelium of the tubules, indicating comparable cell damage.
Summary of the inventionsummary
Without being bound by theory, it is believed that the acquired data supports the hypothesis that venous congestion has a physiologically significant impact on renal function. Specifically, elevated renal venous pressure was observed to reduce urine output by 75% -98% within seconds. The correlation between elevated biomarkers of tubular injury and tissue injury is consistent with the extent of venous congestion produced, both in terms of magnitude and duration of injury.
The data also appears to support the hypothesis that venous congestion reduces the filtration gradient in the medullary nephron by altering interstitial pressure. The changes appear to directly cause hypoxia and cellular damage within the medullary nephron. While this model does not mimic the clinical condition of AKI, it provides insight into mechanically sustained lesions.
The data also appears to support the hypothesis that applying negative pressure to the renal pelvis via ureteral catheters may increase urine output of venous hyperemia models. In particular, negative pressure therapy is associated with increased urine output and creatinine clearance, which may be clinically important. A physiologically significant decrease in medullary capillary volume and a smaller increase in biomarkers of tubular injury were observed. Thus, it appears that negative pressure therapy can directly reduce congestion by increasing urine flow rate and decreasing interstitial pressure in the medullary nephron. Without being bound by theory, by reducing congestion, it can be concluded that negative pressure therapy reduces hypoxia and its downstream effects in the kidney in venous congestion-mediated AKI.
Experimental results appear to support the hypothesis that the extent of congestion is related to the extent of cell damage observed, both in terms of magnitude and duration of pressure. In particular, a correlation between the degree of decrease in urine output and tissue damage was observed. For example, treated pig a with 98% reduction in urine output suffered more injury than treated pig C with 75% reduction in urine output. As expected, control swine D, which encountered a 75% reduction in urine output without therapeutic benefit for 2 and half hours, showed the greatest histological lesions. These findings are in general agreement with human data showing an increased risk of AKI episodes with greater venous hyperemia. See, e.g., legrand, M.et al, association between systemic hemodynamics and septic acute kidney injury in critically ill patients: a retrospective observational study. Critical Care 17:R278-86,2013。
The foregoing examples and embodiments of the invention have been described with reference to different examples. Modifications and alterations will occur to others upon reading and understanding the preceding examples. Accordingly, the foregoing examples should not be construed as limiting the disclosure.
Claims (18)
1. A ureteral catheter, comprising:
(a) A proximal portion; and
(b) A distal portion comprising a retention portion, wherein the retention portion comprises a tapered portion extending radially and longitudinally from a distal end of the proximal portion, the tapered portion corresponding to a curvature of the renal pelvis, the tapered portion comprising a radially outward side and a radially inward side comprising one or more vents, and wherein, when negative pressure is applied through the ureteral catheter, fluid is drawn into the ureteral catheter through the one or more vents while mucosal tissue contacts a periphery of the retention portion to prevent the mucosal tissue from significantly occluding the one or more vents.
2. The ureteral catheter of claim 1, wherein the retention portion comprises a coiled retention portion that extends toward the patient's kidney.
3. The ureteral catheter of claim 1, wherein the proximal portion extends outside the patient's body through the patient's urethra.
4. The ureteral catheter of claim 1, wherein the proximal portion is configured to be connected to a pump for applying negative pressure through the ureteral catheter.
5. The ureteral catheter of claim 1, wherein the proximal portion is located in a bladder of a patient.
6. The ureteral catheter of claim 5, wherein the proximal portion is configured to be in fluid communication with a bladder catheter, and wherein the bladder catheter extends outside the patient's body through the patient's urethra.
7. The ureteral catheter of claim 6, wherein the bladder catheter is configured to be connected to a pump for applying negative pressure through the bladder catheter and ureteral catheter.
8. A ureteral catheter, comprising:
(a) A proximal portion; and
(b) A distal portion comprising a tapered portion extending radially and longitudinally from a distal end of the proximal portion, the tapered portion corresponding to a curvature of the renal pelvis, the distal portion comprising a sidewall comprising a radially outward side and a radially inward side comprising one or more vents, wherein upon application of negative pressure through the ureteral catheter, fluid is drawn into the ureteral catheter through the one or more vents while mucosal tissue contacts the radially outward side and thereby prevents the mucosal tissue from significantly occluding the one or more vents.
9. The ureteral catheter of claim 8, wherein the distal portion includes a coiled retention portion that extends toward the patient's kidney.
10. The ureteral catheter of claim 8, wherein the proximal portion extends outside the patient's body through the patient's urethra.
11. The ureteral catheter of claim 8, wherein the proximal portion is configured to connect to a pump for applying negative pressure through the ureteral catheter.
12. The ureteral catheter of claim 8, wherein the proximal portion is located in a bladder of a patient.
13. The ureteral catheter of claim 12, wherein the proximal portion is configured to be in fluid communication with a bladder catheter, and wherein the bladder catheter extends outside the patient's body through the patient's urethra.
14. The ureteral catheter of claim 13, wherein the bladder catheter is configured to be connected to a pump for applying negative pressure through the bladder catheter and ureteral catheter.
15. The ureteral catheter of claim 1, wherein the retention portion comprises a plurality of coils.
16. The ureteral catheter of claim 15, wherein the plurality of coils extend around a shaft that is a curved arc extending from a central axis of a portion of the ureteral catheter near a proximal portion of the retention portion.
17. The ureteral catheter of claim 1, wherein the retention portion comprises a first diameter and a second diameter, the first diameter being smaller than the second diameter, the second diameter being distal to the retention portion.
18. The ureteral catheter of claim 8, wherein the distal portion includes a first diameter and a second diameter, the first diameter being smaller than the second diameter, the second diameter being distal to the distal portion.
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